LIBRARY GUIDE. Online Courses. March 2012

LIBRARY GUIDE Online Courses March 2012 i

Table of Contents OVERVIEW..................................................................................... 1 COURSE DESCRIPTIONS (LISTED ALPHABETICALLY)............................................... 2 A Guide to ISO 13485 The Quality Management System for Medical Devices (DEV50)............... 2 A Step-by-Step Approach to Process Validation (PHDV79)........................................... 2 A Tour of FDA (PHDV60)........................................................................... 3 A Tour of Health Europe (PHDV90).................................................................. 3 An Introduction to ISO 13485 The Quality Management System for Medical Devices (DEV48)........................................................................ 4 An Introduction to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (FDA56)................................................................. 4 Application of GMPs to Microbiology Laboratories (PHDV72-EU)..................................... 5 Application of GMPs to Analytical Laboratories (PHDV78)........................................... 6 Application of GMPs to Microbiology Laboratories (PHDV72)........................................ 7 Approach to Computerized Systems Validation and Compliance (ISPE02)............................ 7 Awareness of FDA Inspections for Pharmaceutical Manufacturers (PHA65).......................... 8 Basic Food Law for State Regulators (FDA35)........................................................ 8 Basics of HACCP: Overview of HACCP (FDA16)...................................................... 9 Basics of HACCP: Prerequisites Programs and Preliminary Steps (FDA17)............................. 9 Basics of HACCP: The Principles (FDA18)...........................................................10 Batch Record Reviews (PHA53-EU).................................................................11 Batch Record Reviews (PHA53)....................................................................12 Biotechnology: An Overview of Compliance Considerations (PHDV68)..............................13 Bioterrorism Act of 2002 Prior Notice (FDA59)....................................................13 Act of 2002 Registration of Food Facilities (FDA58)...............................................14 Bovine Spongiform Encephalopathy (BSE) (BSE01).................................................14 BSE Inspectional Approach (BSE02)................................................................15 Care and Handling of Drug Product Components, Labeling, Containers, and Closures (PHA41).......15 Care and Handling of Drug Product Components, Labeling, Containers, and Closures (PHA41-EU)...16 Change Control (PHA35)..........................................................................16 Change Control (PHA35-EU)......................................................................17 Collecting Samples and Establishing Limits for Cleaning Validation (PHA54)........................17 Complaint Management for Medical Device Manufacturers (DEV46)................................17 Complaint Management for Pharmaceutical Manufacturers (PHA71)...............................18 Computerized Systems Inspections in the Medical Device Industry (ISPE04).........................18 Conducting Annual Product Reviews (PHA45).....................................................19 Controlling Food Allergens in the Plant (FOOD2)...................................................19 Corrective and Preventive Actions (PHA70)........................................................20 DEA Compliance (PHA40).........................................................................20 Design Control Regulations for Medical Device Manufacturers (DEV40).............................21 iii

Table Online of Contents Courses (Continued) iv Dietary Supplements CGMPS for Manufacturing Plants and Equipment (Dietary 03)...............22 Dietary Supplements - Introduction to Part 111 CGMPs (Dietary 02)................................22 Dietary Supplements Packaging, Labeling, Holding, and Distribution (Dietary 01).................23 Dietary Supplements Production and Process Control System for Manufacturing Operations (Dietary 04)...........................................................................24 Dietary Supplements Requirements for Records and Recordkeeping (Dietary 06)..................25 Documenting the Drug Development Process (ICHQ8) (ISPE07)....................................25 Documenting Validation Activities (PHA55)........................................................26 Effectively Responding to FDA 483s and Warning Letters (PHDV70).................................26 Emergency Preparedness and Response (FDA49)..................................................27 Employee Hygiene: Food Service (FOOD1).........................................................27 Environmental Control and Monitoring (PHDV87)..................................................28 Environmental Control and Monitoring (PHDV87-EU)..............................................28 Essentials of an Effective Calibration Program (PHDV75)...........................................29 EU Medical Device Directive Part II: Specific Procedures (MDD02)..................................29 EU Medical Device Directive Part I: Introduction (MDD01)..........................................30 Failure Investigations for Cosmetic Manufacturers (PC05)..........................................30 Failure Investigations for Medical Device Manufacturers (DEV45)...................................30 Failure Investigations for Pharmaceutical Manufacturers (PHA59)...................................31 Failure Investigations for Pharmaceutical Manufacturers (PHA59-EU)...............................31 FDA Regulated Product Labeling (FDA44)..........................................................32 FDA Training and Qualification Requirements (PHA67).............................................32 Food Code Chapter 1 (FDAFC02)..................................................................33 Food Code Chapter 3: Part I (FDAFC03)............................................................33 Food Code Chapter 3: Part II (FDAFC05)............................................................33 Food Code Chapter 3: Part III (FDAFC06)...........................................................34 Food Code Chapter 5: Water, Plumbing, and Waste (FDAFC04)......................................34 Food Code Chapter 7: Poisonous and Toxic Materials (FDAFC01)....................................34 Food Labeling (FDA45)............................................................................35 Food Microbiological Control 1: Overview of Microbiology (MIC01).................................35 Food Microbiological Control 10: Aseptic Sampling (MIC13)........................................36 Food Microbiological Control 11: Good Manufacturing Practices (MIC14)...........................36 Food Microbiological Control 12: Cleaning and Sanitizing (MIC15)..................................37 Microbiological Control 2A: Gram -Negative Rods (MIC02)..........................................37 Negative Rods and Cocci (MIC03)..................................................................38 Food Microbiological Control 3: Foodborne Viruses (MIC04)........................................39 Food Microbiological Control 4: Foodborne Parasites (MIC05)......................................39 Food Microbiological Control 5: Controlling Growth Factors (MIC06)................................40 Food Microbiological Control 6: Control by Refrigeration and Freezing (MIC07).....................41 Food Microbiological Control 7A: Control by Thermal Processing (MIC08)...........................41 Food Microbiological Control 7B: Control by Pasteurization (MIC09)................................42

Table Online of Contents Courses (Continued) Food Microbiological Control 7C: Control by Retorting (MIC10).....................................43 Food Microbiological Control 8: Technology-based Food Processes (MIC11).........................44 Food Microbiological Control 9: Natural Toxins (MIC12).............................................45 Food Microbiological Control: Mid-Series Exam (MIC16)............................................45 Foodborne Illness Investigations 1: Collecting Surveillance Data (FI01)..............................46 Foodborne Illness Investigations 2: Beginning an Investigation (FI02)...............................46 Foodborne Illness Investigations 3: Expanding the Investigation (FI03)..............................47 Foodborne Illness Investigations 4: Conducting a Food Hazard Review (FI04).......................47 Foodborne Illness Investigations 5: Epidemiological Statistics (FI05)................................48 Foodborne Illness Investigations 6: Final Report (FI06).............................................48 Global Anti-Bribery: UK (RH0041-UK)..............................................................49 Principles for Batch Records (PHA60)..............................................................49 GMP Principles of SOPs (PHA64)...................................................................50 GMP Updates -- Enforcement Changes at the New FDA (PHDV91)..................................50 GMPs for API Bulk Manufacturers (PHA52).........................................................51 Gowning for Sterile Manufacturing (PHA63).......................................................51 Gowning for Sterile Manufacturing (PHA63-EU)...................................................52 GxPs (PHDV61)...................................................................................52 HACCP (FOOD4)..................................................................................53 Handling a Product Recall (PHDV64)..............................................................53 Handling an FDA Inspection (PHDV74)............................................................54 High Purity Water Systems (PHDV82)..............................................................54 How to Meet Drug Retention and Stability Testing Requirements (PHA43)..........................55 ICH Q7A: Introduction and Quality Management (ISPE05)..........................................55 ICH Q7A: Resources and Materials Management (ISPE06)..........................................56 Implementing an Equipment Qualification Program (PHDV88).....................................57 Interviewing Techniques (FDA27).................................................................57 Introduction to GMPs (PHA38)....................................................................58 Introduction to Microbiology (PC04)...............................................................58 Introduction to Quality System Regulations (QSR) (DEV43).........................................58 Introduction to STS Certification (STS-CERT01).....................................................59 Key Concepts of Process Validation (PHDV77).....................................................59 Maintenance and Cleaning of Drug Manufacturing Equipment (PHA44)............................59 Managing FDA Inspections for Pharmaceutical Manufacturers (PHA66).............................60 Medical Device Packaging, Labeling, and Distribution (DEV41).....................................60 GMP Training Requirements (PHDV76).............................................................61 Meeting Process Requirements for Returned and Salvaged Drug Products (PHA42).................61 Orientation to GMP Compliance (PHDV73)........................................................62 Packaging and Labeling of Finished Pharmaceuticals (PHA39).....................................62 Packaging and Labeling of Finished Pharmaceuticals (PHA39-EU)..................................63 Part 11: Electronic Records and Signatures Changes in Enforcement Policy (FDA57)..............63 Part 11: Electronic Records; Electronic Signatures (FDA31)..........................................64 Pre- and Post-Approval FDA Inspections (PHDV66).................................................64 Preventing Microbial Cross-Contamination (FOOD3)...............................................65 v

Table of Contents (Continued) vi Principles of Aseptic Processing (PHDV71).........................................................65 Principles of Aseptic Processing (PHDV71-EU).....................................................66 Principles of Good Documentation (PHDV65-EU)...................................................66 Principles of Sterilisation (PHDV81-EU).............................................................67 Principles of Auditing (PHDV69)...................................................................67 Principles of Cleaning Validation (PHA37).........................................................68 Principles of FDA Inspections for Pharmaceutical Manufacturers (PHA61)...........................69 Principles of Good Documentation (PHDV65)......................................................69 Principles of Good Documentation (PHDV65-EU)...................................................70 Principles of Sterilisation (PHDV81-EU).............................................................70 Principles of Sterilization (PHDV81)................................................................71 Q10 Pharmaceutical Quality System (ISPE11)......................................................72 Q9: Quality Risk Management (ISPE09)............................................................72 QS Regulation 1: Overview and General Provisions (QSR01)........................................73 QS Regulation 10: Servicing; Statistical Techniques (QSR10)........................................73 QS Regulation 11: Application and Inspection of QS Regulation (QSR11)............................74 QS Regulation 2: Quality System Requirements (QSR02)...........................................74 QS Regulation 3: Design Controls (QSR03).........................................................74 QS Regulation 4: Document and Purchasing Controls (QSR04)......................................75 QS Regulation 5: Identification and Traceability; Production and Process Controls (QSR05)...........75 QS Regulation 6: Acceptance Activities; Nonconforming Product (QSR06)...........................75 QS Regulation 7: Corrective and Preventive Action (QSR07)........................................76 QS Regulation 8: Labeling and Package Control; Handling, Storage, Distribution, and Installation (QSR08)...........................................................................76 QS Regulation 9: Records (QSR09).................................................................77 Quality Systems Approach (ISPE10)...............................................................77 Requirements for Computerized Systems Validation and Compliance (ISPE01)......................78 Resolving Out of Specification Test Results (PHA50)................................................78 Review of Basic Statistical Techniques (DEV44).....................................................79 Safety Trained Supervisor (STS) Test Prep 1 (STS-CERT02)...........................................80 Safety Trained Supervisor (STS) Test Prep 2 (STS-CERT03)...........................................80 Testing for Bacterial Endotoxins (PHDV86).........................................................80 The Design and Development of Software Used in Automated Process Controls (PHDV80)..........80 Traceback Investigations 1: Introduction (TI01).....................................................80 Traceback Investigations 2: Point-of-Service Investigations (TI02)...................................80 Traceback Investigations 3: Distributor Investigations (TI03)........................................81 Traceback of Eggs and Other Commodities (TI04)..................................................81 Concluding the Investigation and Reporting the Results (TI05).....................................81 Understanding GMPs for Facilities and Equipment (PHDV63).......................................82 Understanding Post-Approval Changes (PHA49)...................................................82 Understanding the GMP Requirements for Facilities and Equipment (PHDV63-EU)..................83 Understanding the Principles and Practices of Process Controls (PHA47)............................83 Validation of Analytical Laboratory Procedures (ISPE08)............................................84 Vendor Certification for Pharmaceutical Manufacturers (PHDV85)..................................84 Writing and Reviewing SOPs (PHA48)..............................................................85 Writing Validation Protocols (PHA51)..............................................................85

Overview The Kaplan E-Commerce Online Learning Program is designed to support the compliance training needs of individuals and small groups of learners. Using our secure e-commerce site, users can purchase one or multiple courses from the curricula. That curriculum includes 60 courses codeveloped by FDA and and Kaplan EduNeering. Subject areas include FDA Management, Good Manufacturing Practices (GMP), Sales & Marketing (Healthcare Compliance), Environmental Health & Safety, Ethics and more. Each e-learning course is self-paced and takes an average of 45 minutes to complete. Courses can be started and stopped at any time with built in bookmarking. The principles of adult learning and sound instructional design are incorporated into each course, including mastery (quizzes) to demonstrate understanding and proficiency. A minimum of 80% proficiency is required to pass the course, e-sign (21 CFR Part 11 compliant), and receive a certificate of completion. Upon completion, courses remain available for review for one year. 1 Purchasers can buy single or multiple courses, or groups of courses according to a pricing grid that provides a dollar total for the entire purchase. Discounts are incorporated into the pricing, so that the price/course decreases with volume. Note that when using the multiple learner option, each individual will receive the same course(s). AdvaMed members receive a discount. Upon purchase, the buyer will input the email addresses of each learner. Those learners will be notified via email that the course is available within 24 hours of purchase. In addition to the courses, the buyer will receive two reports that track complete and incomplete assignments.

Course Descriptions (Listed Alphabetically) The Quality Management System for Medical Devices (DEV50) This course is designed to describe the basic requirements for ISO 13485 -- the international quality management system for medical devices. The requirements of the standard apply to the methods used in, and the facilities and controls used for, the design and development, production, installation, and servicing of medical devices. 2 Process Approach Quality Management Management s Role Managing Resources Planning Design and Purchasing Production Monitoring and Analysis A Step-by-Step Approach to Process Validation (PHDV79) Using a sample product to demonstrate the nuts and bolts of process validation, this program outlines the important tasks performed during each phase of the validation life cycle. You ll learn what type of information should (and should not) be included in validation documents and why processes must be monitored once they are validated. Tasks commonly executed during the IQ, OQ and PQ Process monitoring Detection and response to variation in processes Revalidation Validation documentation Note: A basic understanding of the principles of process validation is recommended. Key Concepts of Process Validation serves as a prerequisite for this lesson.

A Tour of FDA (PHDV60) FDA-regulated industries must work closely with FDA to comply with industry regulations and create safe and effective products. But how well do your employees know FDA? A Tour of FDA serves as an excellent introduction to the organizational structure of FDA and gives an overview of the different enforcement actions available to this critical Agency. Take a virtual tour of FDA, learning about the function of each Center along the way. Afterwards, explore different actions the Agency may take in order to achieve compliance. FDA background The organizational structure of the FDA Office Of The Commissioner Office Of Regional Affairs The six main program Centers Enforcement actions: Informal enforcement Formal enforcement 3 A Tour of Health Europe (PHDV90) The system in Europe for ensuring safe, effective, and high-quality health products is composed of national authorities in individual countries as well as bodies in the European Union and the Council of Europe. After completing this course, participants will know the organisations that oversee the health industry in Europe and the bodies in those organisations that affect pharmaceutical companies. In addition, participants will know the ways health products can be approved for sale to the public and the system for reporting and tracking defective products. Organisations overseeing the health industry in Europe How the EU works to ensure the health of Europeans The role of the Council of Europe Market authorization Pharmacovigilance

An Introduction to ISO 13485 The Quality Management System for Medical Devices (DEV48) In this course, you will be able to identify why ISO 13485 is different from other quality system regulations and recognize management s role in its implementation. You will also be able to recognize the main clauses of ISO 13485:2003 and why they are critical in terms of an overall quality system. Lastly, you will be able to identify how to prepare to implement ISO 13485:2003. Process Approach Preparation Clauses in ISO 13485 4 An Introduction to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (FDA56) This course is designed to introduce the learner to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (BT Act). It describes the basic structure of the BT Act, its contents, the areas that FDA is responsible for under the BT Act, and how the BT Act will improve the safety of the US food supply. Introduction to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and Food Security The structure of the Bioterrorism Preparedness and Response Act The purpose of the Bioterrorism Preparedness and Response Act How the Act will improve the safety of the nation s food supply

Application of GMPs to Microbiology Laboratories (PHDV72-EU) This program addresses the application of GMP principles to microbiology laboratories and discusses the general principles of GMPs and their importance in microbiology laboratories. Aspects of laboratory operations specifically required by GMPs and considered industry practice will be reviewed, including: general GMP requirements for microbiology laboratories, documents and document control, handling of raw data, and laboratory control. Coverage of general laboratory control issues will be the focus of the program and cover GMP requirements for topics, such as: handling of chemicals, documentation practices, sample handling, prevention of cross-contamination, positive and negative controls, identification tests, sterility tests, handling of media, laboratory equipment, autoclaves, and environmental monitoring. This will be an excellent overview of specific laboratory requirements. GMP requirements for microbiology laboratories Laboratory documents and document control Handling and documentation of raw data Controlling Growth media Aseptic technique Monitoring Laboratory equipment Training practices Out-of-specification results 5

Application of GMPs to Analytical Laboratories (PHDV78) In this course, you will review the specific requirements of Good Manufacturing Practices, or GMPs, as they apply to Analytical Laboratories. It is crucial to understand the impact that GMPs have on everyday laboratory practices. Compliance with GMP requirements is essential in order to create products that are both safe and effective. Control of laboratory documents Specific aspects of day-to-day laboratory practices Requirements for collecting and maintaining raw data Method validation and method verification Calibration requirements for laboratory instruments Training practices required by GMPs Proper handling of OOS (out-of-specification) results GMP requirements for computer systems PHDV78-EU contains the same content as noted above, and also includes EU guidelines. 6

Application of GMPs to Microbiology Laboratories (PHDV72) This program addresses the application of GMP principles to microbiology laboratories and discusses the general principles of GMPs and their importance in microbiology laboratories. Aspects of laboratory operations specifically required by GMPs and considered industry practice will be reviewed, including: general GMP requirements for microbiology laboratories, documents and document control, handling of raw data, and laboratory control. Coverage of general laboratory control issues will be the focus of the program and cover GMP requirements for topics, such as: handling of chemicals, documentation practices, sample handling, prevention of crosscontamination, positive and negative controls, identification tests, sterility tests, handling of media, laboratory equipment, autoclaves, and environmental monitoring. This will be an excellent overview of specific laboratory requirements. GMP requirements for microbiology laboratories Laboratory documents and document control Handling and documentation of raw data Controlling Growth media Aseptic technique Monitoring Laboratory equipment Training practices Out-of-specification results 7 Approach to Computerized Systems Validation and Compliance (ISPE02) This course, the second in a three-part series, describes an approach to the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices that are required to meet FDA s regulations. It outlines the kind of organization, policies and procedures, and plans FDA expects a manufacturing company to establish. This course draws on current industry good practice. Though it also draws on FDA medical device guidance, this course is not intended to describe an approach to developing software that subsequently becomes part of a medical device. Before taking this course, you should have successfully completed Requirements for Computerized Systems Validation and Compliance. Description of a suitable framework for successful validation and compliance Planning and reporting requirement for computerized systems validation Selecting a validation strategy Ongoing activities that the user firm should perform to ensure continuing compliance Note: Content for this course is provided by the International Society of Pharmaceutical Engineers (ISPE) and reviewed by the US Food and Drug Administration as a result of a CRADA between EduNeering and FDA.

Awareness of FDA Inspections for Pharmaceutical Manufacturers (PHA65) In this course, you will be provided with a general awareness of FDA inspections of pharmaceutical testing and manufacturing facilities, including purpose, types, and areas/operations typically inspected. You will also explore how firms should handle FDA inspections and interact effectively with FDA Investigators. After completing this course, you will be able to have a general awareness of FDA inspections of pharmaceutical testing and manufacturing facilities including purpose, types, and areas/operations typically inspected. You will also be able to identify how firms should handle FDA inspections and interact effectively with FDA Investigators. Scope of FDA inspections Procedures for companies to be prepared Guidance on how to interact with FDA What you can expect at the conclusion of an inspection 8 Basic Food Law for State Regulators (FDA35) This course addresses the basic concepts of law that are applied to enforcing food law; the legal requirements that apply to food establishments; the legal remedies available to FDA if the food establishment owner/operator fails to comply with the FD&C Act; the role, responsibilities, and activities of the FDA Investigator; and how the Investigator should prepare for a court appearance. It also addresses the inspection process, decision-making, and the types of evidence that may be collected during an inspection. Hierarchies of law in the United States Basic law concepts that apply to enforcing food law Initial requirements for the owner or operator of a food establishment The role of the public health official The public health official s primary activity Available remedies should the establishment fail to comply The public health official s role in a trial Note: This course is not intended to give legal advice to the reader. The substantive law and legal procedures are different from jurisdiction to jurisdiction.

Basics of HACCP: Overview of HACCP (FDA16) HACCP is a comprehensive management system that addresses food safety through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement, and handling all the way through manufacturing and distribution of the finished product. Government agencies, trade associations, and the food industry around the world have accepted the seven principles of HACCP. Terms and Definitions Origin and History Need for HACCP Benefits of HACCP After completing this course, the learner will recognize terms used in the implementation of HACCP, be familiar with the history of HACCP, and be able to identify its benefits to all segments of the food industry. The learner will also know where to find more HACCP references on the Internet. Basics of HACCP: Prerequisites Programs and Preliminary Steps (FDA17) Hazard Analysis and Critical Control Point (HACCP) is a food safety management system designed for use in all segments of the food industry. This course provides information on the prerequisite programs and preliminary steps that will prepare any facility for HACCP. This course is the second in the three-part Basics of HACCP series. Basics of HACCP: Overview of HACCP is a prerequisite to this course. 9 Prerequisite programs Benefits of prerequisite programs Preliminary steps to implement a HACCP plan HACCP team members Developing product descriptions and production processes Describing the intended use and consumers of a particular product Developing a flow diagram Factors in successful implementations of a HACCP system

Basics of HACCP: The Principles (FDA18) This course provides information on the seven principles of HACCP, which government agencies, trade associations, and the food industry around the world have accepted. This course is the last in the three-part Basics of HACCP series. Basics of HACCP: Overview of HACCP and Basics of HACCP: Prerequisite Programs and Preliminary Steps are prerequisites for this course. The seven principles of HACCP Identifying biological, chemical, and physical hazards Conducting a hazard analysis Critical Control Point (CCP) Establishing critical limits for each CCP Establishing monitoring procedures for each CCP Establishing corrective actions Establishing verification procedures Documentation required in a HACCP system 10

Batch Record Reviews (PHA53-EU) This course defines batch records and describes how to properly perform a batch record review. The course also covers the cgmp requirements for batch records and addresses how to maintain cgmp compliance throughout the review process. After completing this course, you will be able to define batch records and understand the purpose of reviews. You will understand the basic cgmp requirements for batch records. You will be able to explain the key elements and reasons for organized batch records and list many of the key components of batch records. You will identify the elements of compliance and completeness for batch records. Finally, you will understand the scientific and compliance reasoning behind product disposition decisions for many common product and process deviations, and documentation of these decisions. Definition of a batch record review General documentation requirements for cgmp-compliant batch records Organizing a batch record review Key elements of reviewing manufacturing records Components of packaging record reviews Reviewing laboratory data Review issues Batch disposition 11

Batch Record Reviews (PHA53) This course defines batch records and describes how to properly perform a batch record review. The course also covers the cgmp requirements for batch records and addresses how to maintain cgmp compliance throughout the review process. After completing this course, you will be able to define batch records and understand the purpose of reviews. You will understand the basic cgmp requirements for batch records. You will be able to explain the key elements and reasons for organized batch records and list many of the key components of batch records. You will identify the elements of compliance and completeness for batch records. Finally, you will understand the scientific and compliance reasoning behind product disposition decisions for many common product and process deviations, and documentation of these decisions. 12 Definition of a batch record review General documentation requirements for cgmp-compliant batch records Organizing a batch record review Key elements of reviewing manufacturing records Components of packaging record reviews Reviewing laboratory data Review issues Batch disposition

Biotechnology: An Overview of Compliance Considerations (PHDV68) This course provides on overview of the fundamental compliance issues impacting the biotechnology industry. It examines compliance requirements specific to the biotechnology processes such as: cell culture and fermentation; culture media and growth; antibody production; extraction, isolation, and purification; cleaning procedures; and laboratory controls and testing. After completing this course, you will recognize what a biotechnology-derived product is. You will also be able to identify why and how FDA regulates them. You will also be able to identify the key manufacturing process for these products, as well as recognize the challenges involved with working with these products. Finally, you will be able to identify various controls for biotechnologyderived products. BDPs Cell culture Antibody production E-I-P Processing and packaging Controls Testing 13 Bioterrorism Act of 2002 Prior Notice (FDA59) This course is designed to introduce the learner to the Prior Notice of Imported Food regulation as found in 21 CFR Part 1 Subpart 1. It provides an introduction to the regulation and describes what imported foods are subject to the regulation. The course identifies who is subject to the regulation, and what is excluded from Prior Notice. In addition, the course identifies who can submit a Prior Notice, when and how to submit a Prior Notice, and the information required for submitting the Prior Notice. Finally, the course outlines FDA s options after the Prior Notice is reviewed. What the Prior Notice of Imported Food Shipments regulation does Who is responsible for submitting Prior Notice Information that should be provided for Prior Notice What happens to imported food without Prior Notice PREREQUISITES: Before taking this course, learners should complete An Introduction to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and Food Security, and Bioterrorism Act of 2002 - Registration of Food Facilities.

Act of 2002 Registration of Food Facilities (FDA58) This course is designed to introduce the learner to the Registration of Food Facilities regulation as found in 21 CFR Part 1 Subpart H in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). It provides an introduction to the regulation, describes the types of facilities required to register, and identifies exempt facilities. The course identifies both required and optional information and explains how to register. Finally, the course specifies when registration takes effect, the penalties for failing to register, and how to find additional information. The Registration of Food Facilities regulation How a facility registers Type of information collected during registration PREREQUISITES: Before taking this course, learners should complete An Introduction to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and Food 14 Bovine Spongiform Encephalopathy (BSE) (BSE01) This is the first in a series of courses designed to inform the learner of the public health dangers of Bovine Spongiform Encephalopathy (BSE) and its link to new variant Creutzfeldt-Jakob Disease (vcjd) in humans. This course introduces the concept of Transmissible Spongiform Encephalopathies and the characteristics of these diseases. The discovery and expansion of BSE across the United Kingdom and into other European nations is discussed, as well as the precautions being taken to minimize the impact of BSE in the US.

BSE Inspectional Approach (BSE02) This course is the second in a series of web-based courses about BSE. It builds on the information presented in Bovine Spongiform Encephalopathy. After completing this course, you will be familiar with CPGM 7371.009 and be able to identify requirements that apply to each type of firm. You will be familiar with the BSE inspection checklist and with the requirements for labeling and recordkeeping. Finally, you will be able to determine a firm s status for compliance with the BSE feed regulation. FDA BSE/Ruminant feed ban inspections Report of Inspection for Compliance with 21 CFR 589.2000 checklist Categorizing firms for BSE inspections Determining a firm s status with respect to prohibited material Inspections of firms NOT handling prohibited material Inspections of firms handling prohibited material Other considerations for inspections Care and Handling of Drug Product Components, Labeling, Containers, and Closures (PHA41) This lesson is designed to introduce the learner to those practices that control the handling and testing of drug product components, containers and closures while meeting requirements set forth in the GMP Regulations. The learner is introduced to these key concepts by observing a tour of a modern drug manufacturing facility. Proper procedures for the receipt, sampling, storage, testing, and record keeping of drug product components and containers and closures are covered in detail in this lesson. 15 Definitions of components, containers, and closures Impact of components, containers, and closures on drug product safety, purity and effectiveness Receipt, storage, sampling, and testing of components, containers, and closures Documentation and records The relationship of components, containers, and closures to stability and reserve sample programs

Care and Handling of Drug Product Components, Labeling, Containers, and Closures (PHA41-EU) This lesson is designed to introduce the learner to those practices that control the handling and testing of medicinal product starting and packaging materials while meeting requirements set forth in the GMP Regulations. The learner is introduced to these key concepts by observing a tour of a modern medicinal product manufacturing facility. Proper procedures for the receipt, sampling, storage, testing, and record keeping of medicinal product starting and packaging materials are covered in detail in this lesson. Definitions of components, containers, and closures Impact of components, containers, and closures on drug product safety, purity and effectiveness Receipt, storage, sampling, and testing of components, containers, and closures Documentation and records The relationship of components, containers, and closures to stability and reserve sample programs 16 Change Control (PHA35) In this program, the concept of change control is presented in a way that places the learner in the role of a change control manager. Throughout the program, learners learn to state the key elements of a change control program, identify key indicators of change, and learn the regulatory requirements for change control. The program also defines how to identify the groups involved in change control and ways to describe the impact of change on product, process and people. TOPICS INCLUDED: The regulatory requirements for change control Steps in the basic model of change control Indicators of an improper change Elements of change control FDA notification Note: This course is also available in French

Change Control (PHA35-EU) In this programme, the concept of change control is presented in a way that places the learner in the role of a change control manager. Throughout the programme, learners learn to state the key elements of a change control programme, identify key indicators of change, and learn the regulatory requirements for change control. The programme also defines how to identify the groups involved in change control and ways to describe the impact of change on product, process, and people. Collecting Samples and Establishing Limits for Cleaning Validation (PHA54) GMP regulations require that the equipment used in the manufacturing of a drug, medical device, or biologic product be cleaned in such a way as to ensure that the quality, purity, and safety of a product will not be adversely affected. It is also important for manufacturers to set responsible limits for cleaning validation. After completing this course, you will be able to identify the advantages and disadvantages of common sampling methods. You will also be able to recognize the need for established limits of cleanliness in cleaning validation, as well as be able to utilize formulas to derive safe, practical cleaning limits. Sampling locations FDA-preferred sampling methods Advantages and disadvantages of sampling methods Approaches used to set cleanliness limits Factors that influence cleanliness limits Establishing cleanliness limits 17 Complaint Management for Medical Device Manufacturers (DEV46) This course will educate the learner about the importance of properly responding to reports of alleged medical device problems. The learner will be able to apply the knowledge acquired to handle complaint events in a manner that is compliant with FDA regulations. The FDA s definition of a complaint Effective complaint handling systems, including CAPA Complaint file maintenance Investigating a complaint Requirements of the MDR regulation Analysis of complaint data

Complaint Management for Pharmaceutical Manufacturers (PHA71) This course enables you to identify the primary elements in an effective pharmaceutical complaint handling system. You will also recognize how to document complaint information as required by FDA regulations and understand the basic requirements for complaint evaluation and investigation. You will be able to recognize the types of complaints that must be reported to FDA according to the Adverse Drug Experiences regulations, and identify the importance of using statistical techniques to identify complaint trends that may indicate potential quality problems.. TOPICS INCLUDED: System Elements Complaint File Investigation ADE Complaint Analysis 18 Computerized Systems Inspections in the Medical Device Industry (ISPE04) This course has been designed by ISPE and EduNeering, Inc. in cooperation with the FDA/ORA, to assist FDA inspectors in recognizing the critical aspects of computerized systems in the medical device industry. The course explains how computerized systems are used in the medical device manufacturing process and provides an approach to inspecting these systems. This course does not cover the detailed review of software that forms part of a medical device; it covers only inspection of systems that automate part of the device production process or part of the quality system. PREREQUISITE: Requirements for Computerized Systems Validation and Compliance Approach to Computerized Systems Validation and Compliance. Topics include: How computerized systems are used in the medical device industry How an investigator should approach computerized systems The focus of the investigator s review Content for this course is provided by the International Society of Pharmaceutical Engineers (ISPE) and reviewed by the US Food and Drug Administration as a result of a CRADA between EduNeering and FDA.

Conducting Annual Product Reviews (PHA45) This course identifies the regulatory requirements and contents of an Annual Product Review (APR) as well as the possible benefits that APRs can yield. After completing this course you will know the regulatory requirements and contents of an APR as well as the benefits of a good APR program. TOPICS INCLUDED: Annual Product Review (APR) Benefits of APRs Key components of the APR SOP Controlling Food Allergens in the Plant (FOOD2) Each year in the United States, over 20% of all food recalls are allergen related. This course explores the importance of an effective allergen control program. After completing this course, learners will understand the importance of keeping allergenic material separate from non-allergen containing foods. Learners will be able to identify the eight major food allergens in the United States. They will also recognize areas were cross contact can occur with allergenic ingredients and how this can be prevented in the plant environment. Definition of a food allergen 8 major allergens in the U.S. Preventing cross-contact Cleaning and sanitation processes that help prevent cross-contact 19

Corrective and Preventive Actions (PHA70) The failure to take corrective and preventive actions can lead to continuing production problems, high scrap rates, product failures, customer dissatisfaction, and, most seriously, harm to a user or patient. When FDA determines that a company s quality processes are not adequate or followed, they may take enforcement actions to prevent the distribution of the products produced by these processes. After completing this course, you will be familiar with applicable regulatory requirements and other important aspects of implementing an effective corrective and preventive actions (CAPA) procedure. This course was prepared in accordance with FDA s Quality System guidance and learning from the medical device industry. Implementing a CAPA system is a requirement for both the Pharmaceutical and Medical Device industry. TOPICS INCLUDED: 20 Quality System CAPA Program Nonconformities Root Cause Analysis Change Control DEA Compliance (PHA40) This course provides an overview of the regulations found in 21 CFR Chapter 2 governing the manufacture and distribution of drugs classified as controlled substances by the Controlled Substances Act (CSA), and as enforced by the Drug Enforcement Agency (DEA). TOPICS INCLUDED: DEA s role and the laws under the Controlled Substance Act (CSA) DEA s classification of controlled substances DEA requirement for the manufacture and distribution of a controlled substance Production and distribution controls Controls for facilities that manufacture controlled substances Employee controls Record keeping requirements for manufacturers of controlled substances

Design Control Regulations for Medical Device Manufacturers (DEV40) This course introduces the learner to FDA design control regulations by providing basic information about the key procedures followed during the design and development of a product. The design plan requires documentation of training, planning validation, design transfer and changes, formal review, a design history file, and human factors. TOPICS INCLUDED: Design control regulations Eight main aspects of design control, their purpose, requirements, and who is responsible for them Importance of accounting for human factors Frequency of design reviews Categories of verification activities Three general areas of validation General concepts of design transfer Procedures used to implement change control Importance of documentation Dietary Supplements CGMP Requirements for Quality Control (Dietary 05) 21 New regulations for dietary supplement manufacturers require a Quality Control function to oversee manufacturing and packaging operations. Quality Control personnel are expected to ensure the quality of the dietary supplement a manufacturer makes as well as the correct packaging and labeling as specified in the master manufacturing record. In this role, Quality Control must approve or reject factors affecting the identity, purity, strength, or composition of a dietary supplement. This includes processes, specifications, written procedures, controls, tests, and examinations as well as any deviations from or modifications to an operation. In this course, you will be able to identify regulatory requirements for quality control operations, including material review and dispositions, laboratory operations, product complaints, returned products, and other process control operations. Roles of quality control Laboratory operations Material reviews and dispositions Returned products Product complaints Review and approval of manufacturing equipment Master and batch record approvals Packaging and labeling oversight Procedures and records maintenance

Dietary Supplements CGMPS for Manufacturing Plants and Equipment (Dietary 03) The U.S. Federal Drug Administration issued the Dietary Supplement Current Good Manufacturing Practice (cgmp) Final Rule (21 CFR Part 111) in 2007. The regulations cover good practice in all stages of the product s life cycle from manufacturing through packaging and labeling to storage, including ongoing operations, testing, consumer complaint handling, and design. Procedures and practices designed to keep equipment operating properly and to prevent product contamination are a key focus of several specific GMP regulations. This course will familiarize the learner with the FDA requirements for manufacturing plants and grounds including design and construction, and requirements for sanitation, equipment and utensils, automated equipment, contamination prevention, and record keeping. 22 Requirements for manufacturing plants Sanitation in the physical plant Utilities requirements Plant design and construction Important considerations for equipment and utensils Requirements for automated equipment Records and documentation Dietary Supplements - Introduction to Part 111 CGMPs (Dietary 02) In the wake of mounting concerns over contaminated ingredients increasingly found in foods, animal feeds, and health products sold to U.S. consumers, the U.S. Federal Drug Administration (FDA) issued the Dietary Supplement Current Good Manufacturing Practice (cgmp) Final Rule (21 CFR Part 111) in June, 2007. The final rule requires that manufacturing companies maintain proper controls during the manufacturing, packaging, labeling, and holding operations of dietary supplements. After completing this course you will be familiar with the origin and scope of cgmps for dietary supplements. You will also be able to identify the purpose of general provisions and personnel subparts as well as the 16 basic subparts of the 21 CFR Part 111 Final Rules. History of the regulations Application of the DS requirements Definitions clarification Process definitions Basic structure of the final rule

Dietary Supplements Packaging, Labeling, Holding, and Distribution (Dietary 01) FDA reports that approximately 25% of all product recalls are due to packaging and labeling mix-ups. The authors of CGMP regulations understand the dramatic impact that poor packaging and labeling procedures can have on the welfare of consumers. CGMP packaging and labeling requirements were developed primarily to protect consumers. Companies must establish and follow written procedures for fulfilling the requirements of managing and handling of all productrelated materials. These include components used in the manufacture of dietary supplements as well as packing and labeling materials. This also includes instances when a dietary supplement manufacturer may outsource the packaging, labeling, and distribution operations to another company. This course is designed to help the learner become familiar with the requirements for dietary supplement product packaging, labeling, holding, and distribution operations. CGMP principles for packaging and labeling Filling, assembling, and the Master Manufacturing Record Requirements for received materials Packaging and labeling records Holding and distributing operations Reserve samples 23

Dietary Supplements Production and Process Control System for Manufacturing Operations (Dietary 04) Process controls are the principles and practices that help ensure that a dietary supplement product will meet its specifications for quality, purity, strength, and safety. FDA encourages manufacturers to develop process controls that support innovation and efficiency in product development, manufacturing, and quality assurance. This course is designed to help you understand and recognize the principles and practices of process control and the role they play in assuring quality dietary supplement products. After completing this course, you will be able to identify the cgmp process control requirements for manufacturing operations, including sanitation, contamination, rejected products, specifications, in-process adjustments, reserve sampling, and records. 24 Basic process control requirements Establishing control specifications Preventing contamination Collecting representative and reserve samples In-process adjustments and reprocessing Component and product testing Meeting or not meeting specifications Records and documentation

Dietary Supplements Requirements for Records and Recordkeeping (Dietary 06) Effective documentation is an essential part of the production and process control system for assuring product quality. Good documentation is an important GMP requirement; it ensures a complete and accurate record of the manufacturing, packaging, testing, and distribution of a product. However, just creating documents is not enough; you must follow specific established practices that allow everyone who reads your documentation to understand exactly what you mean. Upon completion of this course, you will recognize the importance of the Master Manufacturing Record, Batch Production Records, effective documentation practices, the requirements for records retention, and Part 11 for electronic records. Master manufacturing record Batch production records Quality control records review Best documentation practices Records retention and availability Electronic records - 21 CFR Part 11 25 Documenting the Drug Development Process (ICHQ8) (ISPE07) In this course, the learner will be introduced to the guidance from FDA regarding the documentation of the Drug Development Process via the Common Technical Document. This guidance is part of FDA s initiative to modernize the Current Good Manufacturing Practices (cgmps) and fits with other International Conference on Harmonization (ICH) guidance on Quality. TOPICS: CTD Pharmaceutical Development Drug Components Drug Product Manufacturing Process Container Closure System Microbial Attributes

Documenting Validation Activities (PHA55) The process of validation in FDA-regulated industry is important to gain FDA acceptance. Every step of a particular process must be documented with written procedures and validated with evidence. The key to successful validation is the understanding that validation must be documented. FDA issues Warning Letters to manufacturers that have inadequate validation activities. These observations are considered to be violations of GMP regulations and not violations of validation. This course provides the learner with an overview of the types of documentation that are at the core of sound validation programs. The learner is introduced to the primary documents of validation, as well as the documentation requirements for equipment, materials, processes and products, and personnel. Items that must be validated as specified by GMP requirements Validation documents requirements Equipment validation Proper documentation of materials Process documentation Documentation of Procedures involving Personnel 26 Effectively Responding to FDA 483s and Warning Letters (PHDV70) No company wants to receive an FDA-483 or Warning Letter for adverse findings after an FDA inspection, but it does happen. If an FDA inspection yields any Good Manufacturing Practices (GMP) compliance concerns or faults during the inspection, FDA is required to fill out a report immediately. It is important to understand the purpose and scope of both FDA 483s and Warning Letters so as to be able to respond to them quickly and effectively. After completing this course, you will understand the basic principles of FDA 483s and their use, and the use of Warning Letters. In addition, you will recognize the significance of both these documents. You will also be able to describe the key aspects of written responses to both FDA 483s and Warning Letters FDA 483s Responding to 483s Purpose and scope of Warning Letters Responding to Warning Letters Avoiding mistakes when responding

Emergency Preparedness and Response (FDA49) This course provides an overview of the Federal Response Plan, its basic structure, and use. The course also introduces the Terrorism Incident Annex and demonstrates FDA s role in the event of a Federal emergency. Finally, the course provides an introduction to FDA s Office of Emergency Operations. The Federal Response Plan When is the Federal Response Plan implemented Emergency Support Functions is HHS responsible Purpose of the Terrorism Incident Annex to the FRP The mission of FDA s Office of Emergency Operations Note: Content for this course was provided by the US Food and Drug Administration as a result of a CRADA between FDA and Kaplan EduNeering. Employee Hygiene: Food Service (FOOD1) More than 200 known diseases are transmitted through food. Many cases of foodborne illness are due to poor employee hygiene and food handling practices. This course explores the good hygiene practices for employees who handle and/or prepare food for human consumption. After completing this course, learners will be familiar with a recommended personal hygiene routine they should follow at home and before going to work. Learners will also study the tasks they must complete before actually beginning work, the proper hand washing procedure, and the proper times they should wash their hands at work. Finally, learners will have an opportunity to practice their new information by going through several scenarios of a typical workday. 27 Hygiene practices before leaving home Hygiene practices before beginning work Proper hand washing procedures Glove use Application scenarios

Environmental Control and Monitoring (PHDV87) Many important components and controls are necessary to assure high quality pharmaceutical or medical device products two of the most important are environmental control and environmental monitoring. Environmental control and monitoring go hand-in-hand. Together, they help to create and maintain a manufacturing environment that will prevent product contamination. This course examines the establishment of environmental control elements in the design of GMP operations and the monitoring necessary to assure proper function. It will review the importance of maintaining an acceptable manufacturing environment, including control parameters and related regulatory requirements. TOPICS INCLUDED: An introduction to environmental control and monitoring Components of effective environmental control Facility and equipment design that assure environmental control Personnel practices that ensure effective environmental control Cleaning methods to ensure effective environmental control Necessary contents of the environmental monitoring SOP 28 Environmental Control and Monitoring (PHDV87-EU) Many important components and controls are necessary to assure high quality pharmaceutical or medical device products two of the most important are environmental control and environmental monitoring. The European Union and FDA urge sterile product manufacturers to remain keenly aware of public health implications of distributing a non-sterile product. Environmental control and monitoring go hand-in-hand. Together, they help to create and maintain a manufacturing environment that will prevent product contamination. This course examines the establishment of environmental control elements in the design of GMP operations and the monitoring necessary to assure proper function. It will review the importance of maintaining an acceptable manufacturing environment, including control parameters and related regulatory requirements. TOPICS INCLUDED: An introduction to environmental control and monitoring Components of effective environmental control Facility and equipment design that assure environmental control Personnel practices that ensure effective environmental control Cleaning methods to ensure effective environmental control Necessary contents of the environmental monitoring SOP

Essentials of an Effective Calibration Program (PHDV75) Injuries, fatalities, or major class action suits filed against the manufacturer can result when products are produced with out-of-calibration equipment. When lives are at stake and a company s reputation is in the balance, equipment must always be operating to its precise specifications. This course is designed to help the learner identify the key concepts of calibration, and recognize the importance of calibration reference standards and GMP calibration requirements in order to ensure an effective calibration program. TOPICS INCLUDED: Calibration Calibration standards GMP requirements for the calibration program Essential elements for a calibration program * Also available for Personal Care Products Industry: Course PC01 EU Medical Device Directive Part II: Specific Procedures (MDD02) The European (EU) s Medical Device Directive serves as the basis for the authorization to sell medical devices in the EU market. This training course provides specific information regarding the EU MDD and CE marking of medical devices, including how to assess conformity with the MDD, how to document conformity as well as incidents and events, and how to conduct post-market research and follow-up. 29 TOPICS INCLUDED: Conformity Assessment: How to determine which class a device belongs Clinical Evaluation: Definition and clinical data requirements Technical File: What must be documented, including description, specifications, standards, etc. Risk Management: Based on EN ISO 14971, what the risk management process should include, including analysis, evaluation, control, and post-production information. Post-Market Surveillance: What manufacturers should consider before establishing and operating a PMS system. Follow-Up: Criteria to consider before establishing Post Market Clinical Follow-up (PMCF).

EU Medical Device Directive Part I: Introduction (MDD01) The European (EU) s Medical Device Directive serves as the basis for the authorization to sell medical devices in the EU market. Every employees needs to become familiar with the rules developed by regulatory authorities to keep the market flowing while maintaining accountability for medical device manufacturers. This training course provides basic components of the EU Medical Device Directive, as well as the definitions and classifications that describe the devices that fall under this directive. TOPICS INCLUDED: History and Approaches Quality System: Learn the eight elements of the quality system, as defined in the Directive Classes of Medical Devices: Learn more about the 18 rules described in Directive 92/43/EEC Annex IX 30 Failure Investigations for Cosmetic Manufacturers (PC05) Conducting a failure investigation in a cosmetic environment is a complex process. If the root cause of a failure is not properly identified, there may be additional failures or missed opportunities for improvement of product quality. An effective system for conducting failure investigations can provide a means for preventing recurrences. It is for these reasons that it is important for those in a cosmetic manufacturing environment to know the characteristics of a good failure investigation. This course will familiarize the learner with failure investigations and the key components of a good investigation. Additionally, the learner will also be able to identify how to determine the root cause of a failure and recognize the importance of corrective actions and follow-ups to failure investigations. Failure Investigations for Medical Device Manufacturers (DEV45) This course will explore what a failure is, the regulatory and practical aspects of investigations, and the elements that make these investigations effective. It will also provide guidance on conducting a comprehensive investigation and on developing corrective actions that prevent future recurrences. Product or process failures are often unavoidable events encountered in medical device manufacturing. How you handle these failures, however, can be significant in your ability to maintain a state of control in operations and prevent future failures. The success of a failure investigation can often be tied to whether the investigation was comprehensive enough to actually identify the root cause of the event.

After completing this course, you will be able to recognize the basic definition of failures. You will be able to identify when a failure investigation should occur and the documentation required. You will also be able to describe the basic elements of a comprehensive failure investigation and the steps for management review and follow-up. TOPICS INCLUDED: Medical device product failure and GMP requirements Failure investigations Identifying the root cause of a failure Corrective and preventive actions (CAPA) Follow up the CAPA Documenting and communicating failures, investigations, and CAPA Failure Investigations for Pharmaceutical Manufacturers (PHA59) Conducting a failure investigation in a pharmaceutical environment is a complex process. If the root cause of a failure is not properly identified, there may be additional failures or missed opportunities for improvement of product quality. An effective system for conducting failure investigations can provide a means for preventing recurrences. It is for these reasons that it is important for those in a pharmaceutical manufacturing environment to know the characteristics and requirements of a good failure investigation. This course will familiarize the learner with GMP regulations regarding failure investigations and the key components of a good investigation. Additionally, the learner will also be able to identify how to determine the root cause of a failure and recognize the importance of corrective actions and follow-ups to failure investigations. 31 TOPICS INCLUDED: Events leading to a failure investigation Root cause Corrective action Follow-up in failure investigations Purpose of an investigation report Failure Investigations for Pharmaceutical Manufacturers (PHA59-EU) Conducting a failure investigation in a pharmaceutical environment is a complex process. If the root cause of a failure is not properly identified, there may be additional failures or missed opportunities for improvement of product quality or even a risk to patient safety. An effective system for conducting failure investigations can provide a means for preventing recurrences. It is for these reasons that it is important for those in a pharmaceutical manufacturing environment to know the characteristics and requirements of a good failure investigation. This course will familiarise the learner with GMP regulations regarding failure investigations and the

key components of a good investigation. Additionally, the learner will also be able to identify how to determine the root cause of a failure and recognise the importance of corrective actions and follow-ups to failure investigations. TOPICS INCLUDED: Events leading to a failure investigation Root cause Corrective action Follow-up in failure investigations Purpose of an investigation report 32 FDA Regulated Product Labeling (FDA44) This course addresses label and labeling requirements for FDA regulated products. It covers the necessity of FDA regulations for labels and labeling. This course contains information on the labeling requirements for food, drugs, and other FDA regulated products, and discusses how FDA regulates labels and labeling in both pre-market and post-market stages. Labeling Regulating labeling Food Drugs Other products Pre-market Post-market FDA Training and Qualification Requirements (PHA67) Effective personnel training and qualification can produce a competent workforce, which can lead

to a reduction of errors/deviations, customer complaints, regulatory risk, and operational costs. This course will address the measures required to stay in compliance with FDA regulations, and the requirements needed to implement an effective training and qualification program. This course will identify FDA requirements concerning training and qualification, responsibilities of personnel, records that need to be maintained, and how to measure training and qualification. Personnel training and qualification Who is responsible for personnel training and qualification Requirements for the training and qualification system Specific requirements for training Specific requirements for personnel qualification Metrics can be used to measure training and qualifications Food Code Chapter 1 (FDAFC02) In this course, the learner will be able to recognize the intent of the Food Code, identify its design conventions, and recognize the Code s revision process. The Food Code provides the regulator with a basic tool to determine that acceptable levels of controlling food safety hazards are achieved in the retail segment of the food industry. The regulator applies the stipulations of the Food Code, implementing its underlying purpose of safeguarding public health and ensuring that food is safe, unadulterated, and honestly presented when offered to the consumer. The stipulations are based on scientifically sound information referenced in Annex 2 (References) and explained in Annex 3 (Public Health Reasons/Administrative Guidelines) of the Food Code. 33 Food Code Chapter 3: Part I (FDAFC03) In this course, you will understand and be able to apply the Food Code Chapter 3 Parts 3-1 to 3-3 and 3-6 to 3-8. These provisions of the Food Code address FDA-identified risk factors relating to the food source, protection at and after receipt, preparation, and presentation of food in retail operations. The interventions discussed in this course specifically address controlling conditions that endanger food safety, contribute to food adulteration, or compromise honest presentation. After completing the course, you will be able to recognize characteristics of safe food and identify

sources of food contamination for selected commodities. You will also be able to recognize Food Code provisions relating to protecting food from contamination as well as identify food safety provisions applicable to highly susceptible populations (i.e., consumers at greater risk of foodborne illness). Finally, you will be able to recognize labeling requirements of packaged and unpackaged food and identify information directed at the consumer. Food Code Chapter 3: Part II (FDAFC05) This course introduces provisions in Chapter 3, Parts 3-4 and 3-5, as well as Public Health Information in Annex 3. The course explores interventions that address the following contributing risk factors to foodborne illness: Inadequate cooking and improper holding temperatures. After completing this course, you will be able to recognize the principles that relate to pathogenic microbial growth, survival, and destruction. You will also be able to identify the factors that need to be considered, when establishing minimum cooking times/temperatures, to eliminate potential bacterial pathogens in various raw animal foods. You should also be able to determine which critical limits are to be applied to a particular food prepared in a food establishment. 34 Food Code Chapter 3: Part III (FDAFC06) This course in the Food Code series is designed to introduce the student to provisions in Chapter 3, specifically 3-5, as well as public health information in Annex 3 as it relates to 3-5. The lesson explores interventions that address the risks of improper holding temperatures implicated in foodborne illness. Before taking this course, you should complete Food Microbiological Control 1: Overview of Microbiology. After completing this course, you will be able to identify the conditions for the proper slacking, thawing, cooling, and holding of foods to prevent microbial growth. You will also understand and be able to identify the stipulations for the date marking of foods and the conditions of using time only as a public health control. Additionally, you will be able to recognize when variances are needed for specific food processes and the criteria for the use of reduced oxygen packaging of foods. Food Code Chapter 5: Water, Plumbing, and Waste (FDAFC04) This course introduces the learner to the water, plumbing, and waste provisions in Chapter 5. Learners will examine the definition for an approved water source and/or system and the requirements for water use and storage at a temporary food facility. For example, water must be obtained from a source in compliance with law and must be used, transported, and dispensed in a sanitary and safe manner. After completing this course, you will be able to recognize the definition for an approved water

source and/or system, recognize the requirements for water use and storage at a temporary food facility, and identify the requirements for the storage and disposal of refuse, returnables, and recyclables. Food Code Chapter 7: Poisonous and Toxic Materials (FDAFC01) This course is designed to assist the regulator in understanding and applying Food Code provisions that address the presence, use, and storage of poisonous and toxic materials in the food establishment. After completing this course, learners will be able to recognize the criteria for the presence and use of poisonous and toxic materials in a facility; distinguish between various categories of poisonous and toxic materials; and recognize the applicable regulations pertaining to the use of such materials. In addition, the regulator should be able to recognize proper application, labeling, and storage practices for poisonous and toxic materials. Food Labeling (FDA45) This course provides a brief introduction to many of the key food labeling requirements. It addresses topics such as misbranding, nutritional information, and special food requirements. It also outlines enforcement measures that FDA will take to bring misbranded products into compliance. TOPICS INCLUDED: 35 Misbranding Requirements for labeling design Labeling requirements for nutritional information Specialty products addressed by FDA regulations Enforcement of food labeling requirements Food Microbiological Control 1: Overview of Microbiology (MIC01) This course will provide information and demonstrate the application of basic microbiology, Good Manufacturing Practices (GMPs), retail Food Code, and sanitation practices when conducting food inspections at the processing and retail levels. The course is an overview of Microbiology and emphasizes controls necessary to prevent foodborne pathogens from causing disease. This knowledge is a foundation for other courses offered by the Food and Drug Administration (FDA).

Overview of Microbiology Microorganisms found in food Binary fission of bacteria Growth of bacteria Foodborne illnesses caused by bacteria Conventional testing methods for bacteria Rapid test methods for bacteria After completing this course, you should be able to identify microorganisms that may be found in food, describe the growth phases of bacteria, explain the ideal conditions for bacterial growth, recognize types of foodborne illnesses, and recognize conventional and rapid methods of testing for bacteria in food. Although this course mainly addresses bacteria, much of the information also applies to controlling yeasts and molds 36 Food Microbiological Control 10: Aseptic Sampling (MIC13) This course is the thirteenth course in the Food Microbiological Control series and emphasizes sampling practices that avoid contamination during the collection process. This course will provide information and demonstrate the application of basic microbiology, Good Manufacturing Practices (GMPs), the Retail Food Code, and sanitation practices when conducting food inspections at the processing and retail levels. This knowledge is a foundation for other courses offered by FDA. When aseptic sampling techniques should be used Preparing for collecting aseptic samples What aseptic sampling equipment to pack Types of aseptic samples to collect Maintaining sample integrity Documentation that must accompany an aseptic sample Food Microbiological Control 11: Good Manufacturing Practices (MIC14) This is the fourteenth course in the Food Microbiological Control series and emphasizes prerequisite programs that control the in-plant environment conditions that provide a foundation for safe food production. This course will demonstrate the application of basic microbiology, Good

Manufacturing Practices (GMPs), the Retail Food Code, and sanitation practices when conducting food inspections at the processing and retail levels. This knowledge is a foundation for other courses offered by FDA. Water safety Contact surfaces Cross-Contamination Sanitary facilities Areas in a facility that can be hazardous to food Toxic compounds Health conditions Pest control Food Microbiological Control 12: Cleaning and Sanitizing (MIC15) This course is the fifteenth course in the Food Microbiological Control series and emphasizes cleaning and sanitation practices for food processing equipment. This course will provide information and demonstrate the application of basic microbiology, Good Manufacturing Practices (GMPs), the Retail Food Code, and sanitation practices when conducting food inspections at the processing and retail levels. This knowledge is a foundation for other courses offered by FDA. 37 Process used to clean and sanitize equipment Frequency of cleaning and sanitizing equipment Cleaning and sanitizing the equipment Clean-in-place system (CIP) Four types of chemical sanitizers Two types of thermal sanitizers Microbiological Control 2A: Gram -Negative Rods (MIC02) This course will provide information and demonstrate the application of basic microbiology, Good Manufacturing Practices (GMPs), the retail Food Code, and sanitation practices when conducting food inspections at the processing and retail levels. The course emphasizes controls necessary to prevent gram-negative rods that are foodborne pathogens from causing disease. This knowledge is

a foundation for other courses offered by the Food and Drug Administration (FDA). Overview of gram-negative rods Yersinia Salmonella Shigella Campylobacter E. coli Vibrio After completing this course, you will be able to identify some of the growth characteristics of foodborne bacterial pathogens, symptoms and characteristics of diseases that they cause, some potentially hazardous foods and processes associated with these pathogens, and some of the control measures that will enable you to minimize the potential for foodborne illnesses due to these pathogens. 38 Negative Rods and Cocci (MIC03) This course will provide information and demonstrate the application of basic microbiology, Good Manufacturing Practices (GMPs), retail Food Code, and sanitation practices when conducting food inspections at the processing and retail levels. The course emphasizes controls necessary to prevent gram-positive rods and cocci that are foodborne pathogens from causing disease. This knowledge is

a foundation for other courses offered by the FDA. Overview of gram-positive rods and cocci Listeria Clostridium perfringens Clostridium botulinum Bacillus cereus Staphylococcus aureus After completing this course you should be able to: identify some of the growth characteristics and sources of foodborne bacterial pathogens; recognize some of the symptoms and characteristics of diseases caused by pathogens; identify some potentially hazardous foods and processes associated with pathogens; and recognize some of the control measures needed to minimize the potential for foodborne illness. Food Microbiological Control 3: Foodborne Viruses (MIC04) This course will provide information and demonstrate the application of basic microbiology, Good Manufacturing Practices (GMPs), the Retail Food Code, and sanitation practices when conducting food inspections at the processing and retail levels. The course emphasizes controls necessary to prevent viruses that are foodborne pathogens from causing disease. Courses 1, 2A, and 2B must be completed before taking this course and at least a high school level knowledge of biology is advised. This knowledge is a foundation for other courses offered by the FDA. 39 Bacteria vs. Viruses Transmission Detecting Viruses Hepatitis A Virus (HAV) Norwalk-like Viruses (SSRVs) Control After completing this course you should be able to distinguish between bacteria and viruses, describe how foodborne viruses are transmitted, identify characteristics of Hepatitis A Virus (HAV) and Norwalk-like viruses (SRSVs), and explain methods used to control viral foodborne illnesses. Food Microbiological Control 4: Foodborne Parasites (MIC05) This course will provide information on and demonstrate the application of basic microbiology, Good Manufacturing Practices (GMPs), the Retail Food Code, and sanitation practices when conducting food inspections at the processing and retail levels. The course emphasizes the controls necessary to prevent parasites that are foodborne pathogens from causing disease. Courses 1, 2A,

2B, and 3 must be completed before taking this course and at least a high school level knowledge of biology is advised. This knowledge is a foundation for other courses offered by the FDA. Protozoa Nematodes Trematodes Cestodes Transmission Control After completing this course you should be able to recognize some of the characteristics of foodborne parasitic protozoa, including Nematodes, Trematodes, and Cestodes, recognize how foodborne parasites are transmitted, and identify some effective control measures for foodborne parasites. 40 Food Microbiological Control 5: Controlling Growth Factors (MIC06) This series of courses will provide information and demonstrate the application of basic microbiology, Good Manufacturing Practices (GMPs), retail Food Code, and sanitation practices when conducting food inspections at the processing and retail levels. This course is the fifth course in the Food Microbiological series and emphasizes controlling growth factors to prevent foodborne pathogens from causing disease. This knowledge is a foundation for other courses offered by FDA.

ph Acidification Requirements Water Activity Control Chemicals Packaging Concerns Hurdle Concept Microbiological controls using knowledge of ph, water activity, chemical inhibitors, and atmosphere (packaging) will be outlined in this course. After completing this course, you should be able to determine whether a food meets safety requirements through control of ph, water activity, chemical inhibitors, and packaging. Food Microbiological Control 6: Control by Refrigeration and Freezing (MIC07) This course is the seventh course in the Food Microbiological Control series and emphasizes controls necessary to prevent foodborne pathogens from causing disease. This course will provide information and demonstrate the application of basic microbiology, Good Manufacturing Practices (GMPs), the Retail Food Code, and sanitation practices when conducting food inspections at the processing and retail levels. This knowledge is a foundation for other courses offered by FDA. 41 Temperature Rapid cooling Pre-cooling Walk-in coolers Thermometers PREREQUISITES: Courses 1, 2A, 2B, 3, 4, and 5 in the Food Microbiological Control series must be completed before taking this course. It is advised that the user have at least a high school level knowledge of biology. Food Microbiological Control 7A: Control by Thermal Processing (MIC08) This course is the eighth course in the Food Microbiological Control series and emphasizes controls by thermal processing. This course will provide information and demonstrate the application of basic microbiology, Good Manufacturing Practices (GMPs), the Retail Food Code, and sanitation practices when conducting food inspections at the processing and retail levels. This knowledge is a foundation for other courses offered by FDA.

Three basic methods of heating Death factors Death rate Blanching Cooking Cooking control Other methods of thermal processing Container integrity PREREQUISITES: Courses 1, 2A, 2B, 3, 4, 4A, 5, and 6 in the Food Microbiological Control series must be completed before taking this course. It is advised that the user have at least a high school level knowledge of biology. 42 Food Microbiological Control 7B: Control by Pasteurization (MIC09) This course is the ninth course in the Food Microbiological Control series and emphasizes controls by pasteurization. This series of courses provides information about and demonstrates the application of basic microbiology, Good Manufacturing Practices (GMPs), the Retail Food Code,

and sanitation practices when conducting food inspections at the processing and retail levels. This knowledge is a foundation for other courses offered by FDA. Pasteurization Low temperature/long time (LTLT) pasteurization High temperature/short time (HTST) pasteurization Other types of pasteurizers Pasteurizing food in finished product containers PREREQUISITES: Courses 1, 2A, 2B, 3, 4, 5, 6, 7A, and the mid-series exam in the Food Microbiological Control series must be completed before taking this course. It is advised that the user have at least a high school level knowledge of biology. Food Microbiological Control 7C: Control by Retorting (MIC10) This course is the tenth course in the Food Microbiological Control series and emphasizes control by retorting. This series of courses provides information about and demonstrates the application of basic microbiology, Good Manufacturing Practices (GMPs), the Retail Food Code, and sanitation practices when conducting food inspections at the processing and retail levels. This knowledge is a foundation for other courses offered by FDA. 43 Retorting

Heat resistance study Heat penetration study Factors that affect the heat penetration of a product The purpose of a temperature distribution study A horizontal still retort Other types of still retorts Agitating retorts How water-based retorts are different than steam retorts PREREQUISITES: Courses 1, 2A, 2B, 3, 4, 5, 6, 7A, 7B, and the mid-series exam in the Food Microbiological Control series must be completed before taking this course. It is advised that the user have at least a high school level knowledge of biology. 44 Food Microbiological Control 8: Technology-based Food Processes (MIC11) This course is the eleventh course in the Food Microbiological Control series and emphasizes technology-based food processes that have the potential to reduce or eliminate pathogens in food. This series of courses provides information about and demonstrates the application of basic microbiology, Good Manufacturing Practices (GMPs), the Retail Food Code, and sanitation practices when conducting food inspections at the processing and retail levels. This knowledge is a foundation for other courses offered by FDA. Irradiation Gamma rays

Electron beams Pulsed light Electric fields UV light High-pressure processing (HPP) Ohmic heating Ozone processing PREREQUISITES: Courses 1, 2A, 2B, 3, 4, 4A, 5, 6, 7A, 7B, 7C, and the mid-series exam in the Food Microbiological Control series must be completed before taking this course. It is advised that the user have at least a high school level knowledge of biology. Food Microbiological Control 9: Natural Toxins (MIC12) This course is the twelfth course in the Food Microbiological Control series and emphasizes identification and descriptions of toxins that naturally occur in shellfish, finfish, agricultural products, mushrooms, and honey. This series of courses provides information about and demonstrates the application of basic microbiology, Good Manufacturing Practices (GMPs), the Retail Food Code, and sanitation practices when conducting food inspections at the processing and retail levels. This knowledge is a foundation for other courses offered by FDA. 45 Types of poisoning caused from toxins found in molluscan shellfish Scombroid poisoning (also called Histamine poisoning) Ciguatera poisoning Tetrodotoxin poisoning Agricultural toxins Mushroom poisoning Honey intoxication PREREQUISITES: Courses 1, 2A, 2B, 3, 4, 5, 6, 7A, 7B, 7C, 8, and the mid-series exam in the Food Microbiological

Control series must be completed before taking this course. It is advised that the user have at least a high school level knowledge of biology. Food Microbiological Control: Mid-Series Exam (MIC16) This exam is based on the information covered in the following courses: Food Microbiological Control 1: Overview of Microbiology Food Microbiological Control 2A: Gram-Negative Rods Food Microbiological Control 2B: Gram-Positive Rods and Cocci Food Microbiological Control 3: Foodborne Viruses Food Microbiological Control 4: Foodborne Parasites This exam is to be used after course 4 of the Food Microbiological Control course. 46 Foodborne Illness Investigations 1: Collecting Surveillance Data (FI01) This is the first course in the Foodborne Illness Investigations series. It covers the collection of data from several different sources, which are categorized into two surveillance methods. The reportable disease process used in the U.S. will be discussed, as well as the use of a surveillance log for specific reporting periods. Collecting surveillance data Passive surveillance Surveillance log Active surveillance Food Safety and Inspection Service (FSIS) and the CDC s FoodNet (formally Sentinel Site Study) CDC s PulseNet PREREQUISITES: Participants must complete Orientation to ORA and FDA Fieldwork and the Food Microbiological Control series. Foodborne Illness Investigations 2: Beginning an Investigation (FI02)

This second course in the Foodborne Illness Investigations series provides information for preparing for a foodborne illness investigation. This includes the processes of gathering initial information, developing a hypothesis, and defining a case. Preparation for an investigation Assembling an investigation team Gathering information in an initial consumer complaint Obtaining a food history Developing a case definition PREREQUISITES: Participants must complete Orientation to ORA and FDA Fieldwork, the Food Microbiological Control series, and Foodborne Illness Investigations 1: Collecting Surveillance Data. Foodborne Illness Investigations 3: Expanding the Investigation (FI03) This course provides information on expanding a foodborne illness investigation. It covers interviews, case definitions, questionnaires, epidemic curves, control measures, and media interactions. 47 Conducting a thorough interview Handling outbreak related cases Gathering more details though questionnaires Developing a line list Defining an epidemic curve Implementing control measures Dealing with the media PREREQUISITES: This is the third course in the Foodborne Illness Investigations series. Prerequisites include Orientation to ORA and FDA Fieldwork, the Food Microbiological Control series, Foodborne Illness Investigations 1: Collecting Surveillance Data, and Foodborne Illness Investigations 2: Beginning an Investigation. Foodborne Illness Investigations 4: Conducting a Food Hazard Review (FI04) This is the fourth course in the Foodborne Illness Investigations series. This course will provide information on how to conduct a food hazard review, including what to look for, how to collect samples, and what to consider when implementing control measures.

Defining a food hazard review Identifying food hazards Planning for a food hazard review Conducting a food hazard review Collecting samples Defining samples to be collected Protecting the public during an investigation Managing inconsistent information PREREQUISITES: Participants must complete Orientation to ORA and FDA Fieldwork, the Food Microbiological Control series, and the first three courses in the Foodborne Illness Investigations series before taking this course. 48 Foodborne Illness Investigations 5: Epidemiological Statistics (FI05) This is the fifth course in the Foodborne Illness Investigations series. This course will provide information on basic statistical analyses of outbreak data. This includes understanding the mean, median, and range of data, measures of confidence and association, cohort studies, case-control studies, statistical hypotheses, and causal relationships. Statistically describing a population at risk Statistically determining now much confidence to place in an investigation s results Defining a cohort study Defining a case-control study The value of developing a statistical hypothesis Defining the criteria for inferring a causal relationship between an implicated food and illness PREREQUISITES: Participants must complete Orientation to ORA and FDA Fieldwork, the Food Microbiological Control series, and Foodborne Illness Investigations 1-4 before taking this course. Foodborne Illness Investigations 6: Final Report (FI06)

This is the sixth course in the Foodborne Illness Investigations series. This course provides information on how to generate a final report for an investigation and emphasizes why final reports are valuable resources. Writing a final report Defining the components of a final report A 10-step guideline for writing your reports PREREQUISITES: Participants must complete Orientation to ORA and FDA Fieldwork, the Food Microbiological Control series, and Foodborne Illness Investigations 1-5 before taking this course. Global Anti-Bribery: UK (RH0041-UK) The UK Anti-bribery law has now eclipsed the U.S. FCPA as the broadest anticorruption legislation in the world. Companies located or doing any business in the UK are subject to the law, which prohibits not only improper payments to foreign government officials, but extends to commercial bribery as well. Corruption distorts markets and inhibits competition, and legislation to curtail such corruption is the subject of increasing international enforcement cooperation. 49 After completing this course, you ll be able to identify the main provisions of the UK Anti-bribery Act, and will understand key ways in which the law compares with other Anti-bribery laws around the world. This is particularly important for those who may be familiar with some of the exceptions under, for example, the FCPA (like facilitation payments) that are not included in the Act. You will also be able to recognize when to report a violation and the consequences for violating the law. Principles for Batch Records (PHA60) Pharmaceutical batch records are essential to ensuring that regulatory and product quality attributes are achieved. In this course, you will explore the required components of batch records and the importance of carefully documenting the information generated during the manufacturing,

packaging, and in-process testing of pharmaceutical products. This course is intended for manufacturing and packaging operators who perform functions directly related to producing a batch of material or product and who record critical data on batch records. Batch records FDA requirements for cgmp-compliant batch records Manufacturing records Packaging batch records Deviations Batch record review 50 GMP Principles of SOPs (PHA64) This course reviews the principles of SOPs for an FDA regulated environment and provides employees with a working knowledge of what SOPs are, their purpose, how they are structured, information provided, change control, and how SOPs are used in the workplace. After completing this course, you will be able to identify what SOPs are, their purpose, and how they are structured. You will be able to recognize how to handle changes to SOPs, as well as how SOPs are used in the workplace. What are SOPs What information is contained in an SOP Change control Implementation of SOPs in the workplace GMP Updates -- Enforcement Changes at the New FDA (PHDV91) After completing this course, you will be familiar with the significant changes coming to the FDA in its stepped up emphasis on inspections, warning letters, enforcement, and follow up. You will learn

about the challenges facing FDA and the industry with outsourcing manufacturing, and you will also learn about what companies can do to prepare for the coming changes. Current Environment Enforcement Model Expectations Supply Chain Supplier Monitoring Prevention Future GMPs for API Bulk Manufacturers (PHA52) The Food, Drug, and Cosmetic Act requires Active Pharmaceutical Ingredients (APIs) to be manufactured in accordance with cgmps. There are, however, no specific regulations in 21 CFR for APIs like there are for drug products. The FDA are proposing regulations, however, they are not yet final. This course is about the basic concepts of Good Manufacturing Practices (GMPs) and how they can be applied to the manufacture of APIs. 51 cgmp requirements for API manufacturing Personnel GMP requirements for building and facilities cgmp requirements for manufacturing equipment Requirements for materials and packaging components Process controls for APIs Laboratory controls for APIs Recordkeeping requirements Gowning for Sterile Manufacturing (PHA63) In this course you will be able to identify important sources and types of contamination in a

manufacturing environment, recognize the importance of health issues and personal hygiene, and describe the staged entry and use of cleanrooms. You will also be able to identify important practices and procedures for proper gowning. Before taking this course, make sure you have completed Principles of Aseptic Processing and Principles of Sterilization. After completing this course, you ll be able to identify important sources and types of contamination in a manufacturing environment, recognize the importance of health issues and personal hygiene, and describe the staged entry and use of cleanrooms. You ll also be able to identify practices and procedures for proper gowning. 52 Why gowning is important Types of contamination Preparation in gowning rooms Gowning basics and procedures Gowning for Sterile Manufacturing (PHA63-EU) In this course you will be able to identify important sources and types of contamination in a manufacturing environment, recognise the importance of health issues and personal hygiene, and describe the staged entry and use of cleanrooms. You will also be able to identify important practices and procedures for proper gowning. The course covers requirements of the European Union (EU) and FDA. Before taking this course, make sure you have completed Principles of Aseptic Processing and Principles of Sterilisation. Why gowning is important Types of contamination Preparation in gowning rooms Gowning basics and procedures GxPs (PHDV61) GxP is a collective term for the regulations known as Good Laboratory Practices, Good Clinical

Practices, and Good Manufacturing Practices. Without these combined regulations the safety and efficacy of the pharmaceutical and medical device products would be in question. After completing this course, you will know what practices comprise the GxP regulations. You will also learn how these practices relate to each step in the development and manufacture of new drugs, biologics, and medical devices. This course references regulations that can be found in the Code of Federal Regulations Title 21. GxPs GLPs GCPs GMPs Note: This course is also available in French HACCP (FOOD4) HACCP is a science-based system designed to prevent food safety incidents before they occur, and correct problems as soon as they are detected. HACCP is only part of a comprehensive food safety program. Everyone in the food plant is responsible for ensuring food safety. After completing this course, learners will understand hazards that affect food safety, will be able to recognize the purpose and functions of a HACCP plan, and will understand their role in performing tasks related to HACCP. 53 Seven HACCP principles Types of hazards and how to prevent them Definition of CCPs and critical limits Importance of performing monitoring tasks exactly as defined Effectively recording information required by the HACCP Program Handling a Product Recall (PHDV64) Companies undergo product recalls for various problems; it could even happen to your company. A product recall is probably the most difficult and stressful situation that can be encountered in

this industry. Because product recall can be critical, you need to understand what it is and how to handle it. This lesson defines product recalls and explains their impact on the manufacturer, FDA s requirements and enforcement when dealing with a product recall, and the basic steps for handling a recall. TOPICS INCLUDED: Product recalls Steps in conducting a recall Roles and responsibilities during product recall Effect a recall on a company Who a company must communicate with during a recall 54 Handling an FDA Inspection (PHDV74) This course reviews the basics of handling an FDA inspection of a pharmaceutical and medical device manufacturing facility. The course will clarify the roles and responsibilities of personnel during an inspection with an emphasis on being prepared and maintaining a positive, professional relationship with FDA. TOPICS INCLUDED: Personnel Conduct Inspection Types The Process Records Samples and Photos Enforcement End of Inspection High Purity Water Systems (PHDV82) Water is one of the most important materials used in the manufacturing of pharmaceutical and medical device products. Because water quality can directly impact product quality GMP regulations require that water receive the same scrutiny, monitoring, and control as any other critical raw material used in manufacturing processes. As a result, FDA investigators commonly cite manufacturing firms for their failure to assure the quality of water in use.

After completing this course, you will be able to identify the typical uses of water in pharmaceutical and medical device manufacturing. You will also be able to recognize the general process for producing high quality water, various approaches for monitoring a water system, and possible methods of solving water system problems. Defining high purity water Types or qualities of water Determining the quality of the required water Steps for producing WFI water Monitoring high purity water systems Monitoring approaches Water system problems Correcting water system problems How to Meet Drug Retention and Stability Testing Requirements (PHA43) This course is designed to provide the learner with an understanding of the principles of drug stability testing and requirements for maintaining reserve samples. After completing this course, you will recognize the importance of maintaining drug safety and effectiveness over a product s shelf life. You will be familiar with basic Principles of Stability and the relationship to product safety and effectiveness. You will also be familiar with reserve sample regulations and retention testing programs. 55 Stability testing program Effects of environmental conditions on product stability Determining shelf life Requirements for stability testing protocols Purpose of retention testing ICH Q7A: Introduction and Quality Management (ISPE05) This is the first in a series of courses designed to instruct on current good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs), as set out by the ICH Q7A Guideline. This course covers the Introduction to ICH Q7A and Quality Management for API manufacture. The learner should have a working knowledge of current GMPs for drug products as set out in the Code of Federal Regulations, CFR 21 Parts 210 and 211, as well as a basic understanding of chemical and biological processes used in the manufacture of Active Pharmaceutical Ingredients. After completing this course, you will be able to describe the purpose of the Q7A Guideline and how it fits in with current regulatory expectations and practices in the United States especially

in the context of the FDA s systems-based inspections program, 7356.002F. You will also be able to recognize the basic terminology and applications of Q7A and the principles of an effective quality management system for API manufacture. TOPICS: What is Q7A How APIs differ from drug products When Q7A guidelines apply to the API manufacturing process The purpose of quality management Key Production activity that ensures API quality Why a formal change control system is needed What complaints and recalls share in common Note: Content for this course was provided by ISPE and reviewed by the US Food and Drug Administration as a result of the CRADA between EduNeering and FDA. 56 ICH Q7A: Resources and Materials Management (ISPE06) This is the second in a series of courses designed to instruct on Good Manufacturing Practices (GMPs) for Active Pharmaceutical Ingredients (APIs), as set out by the ICH Q7A Guideline. This course covers qualifications for personnel, requirements for buildings used in API manufacturing, considerations for API manufacturing equipment, and materials management. Learners should have a working knowledge of current GMPs for drug products as set out in CFR 21 Parts 210 and 211. Learners should also have a basic understanding of chemical and biological processes used in the manufacture of Active Pharmaceutical Ingredients. Learners should have completed the course ICH Q7A: Introduction and Quality Management.

After completing this course, you will be able to identify the general requirements for qualification of API manufacturing personnel. You will be able to identify the requirements for buildings and facilities as well as API manufacturing equipment. You will also be able to recognize materials management and warehousing and distribution procedures. TOPICS: Personnel qualifications Buildings and facilities requirements used for API manufacturing Process equipment requirements used for API manufacturing Purpose of materials management Storage/Distribution Note: Course content was provided by ISPE and reviewed by the US Food and Drug Administration as a result of the CRADA between EduNeering and FDA. Implementing an Equipment Qualification Program (PHDV88) Equipment qualification serves as the foundation for several currently recognized health care industry compliance requirements, such as analytical method, process, cleaning, and automated systems validation. A well-developed and established equipment qualification program allows a company to meet current GMP requirements and save operational costs at the same time. This course is designed to provide an introductory overview of the equipment qualification requirements that apply to the pharmaceutical, biotechnology, and medical device industries. After completing this course, you will be able to define equipment qualification, identify the importance of equipment qualification, recognize the GMP requirements in this area, and identify the steps that must be followed in order to successfully implement equipment qualification. Importance of equipment qualification Equipment qualification protocol Design qualification (DQ) Installation qualification (IQ) Operational qualification (OQ) Performance Qualification (PQ) Legacy equipment qualification (LEQ) 57 Interviewing Techniques (FDA27) Interviews are an important part of virtually every operation performed by FDA inspectors, investigators, and analysts. Interviews are conducted during inspections, sample collections, recalls, and special investigations; therefore, it is important that FDA field personnel possess good interviewing skills and develop them as they move forward in their careers.

After completing this course you will be able to recognize the fundamentals of conducting an effective interview. You will be able to identify the traits of a successful interviewer and the importance of appropriate interpersonal skills. You will also be able to identify appropriate questioning techniques to use in an interview. Purpose of an interview Preparing for an interview Specific considerations for the persons being interviewed Traits of a successful interviewer Keys to asking effective questions Nonverbal behaviors you should observe Introduction to GMPs (PHA38) In this course, you ll examine the history of GMPs, and explore the importance of training, as well as quality control and personal responsibilities. In addition, you ll discover the importance of documentation and tracking practices. 58 Procedures Documentation Responsibilities Contamination Control Inspections Introduction to Microbiology (PC04) This course explores the importance of regulating personal care products and ensuring that they are not contaminated with certain microorganisms. Learners will be able to identify different types of microorganisms that can contaminate personal care products, and identify how they grow. This course is appropriate for microbiologists, quality assurance specialists, regulatory specialists, product developers and managers, and legal team members.

Introduction to Quality System Regulations (QSR) (DEV43) Employees play an active part in ensuring the quality of the product. This interactive program provides employees with an overview of FDA s current Quality Systems Regulation for medical devices. Mastery of these concepts will provide employees with a good understanding of how the Quality System Regulation affects operations in manufacturing facilities. This program emphasizes the elements of a Quality System that help to ensure products are safe and effective and that manufacturing operations are compliant with current medical device Good Manufacturing Practices. This interactive program provides an overview of the major elements of a Quality System, including: Management responsibilities Design controls Document controls Process controls Purchasing controls Corrective and preventive actions Device labeling and packaging procedures Training 59 Introduction to STS Certification (STS-CERT01) This course explores the Safety Trained Supervisor (STS) certification program. It discusses the importance and value of the STS certification, as well as the qualifications, rules, and procedures for registering and taking the certification exam. Key Concepts of Process Validation (PHDV77) Through the use of interactive examples focused on producing a fictitious product, this program will outline the actual activities that take place before, during, and following the validation of a process. Throughout the program, you will learn terminology and concepts related to the validation of manufacturing processes, the regulatory requirements for process validation, and validation approaches. A validation life cycle model is used to explain the major elements of validation and how they relate to one another. After completing this course, you will be familiar with applicable regulatory requirements and other important aspects of process validation. The validation life cycle, which lays out the steps to effective process validation, will also be introduced. Why processes are validated Process validation vs. verification Types of processes that must be validated

Common approaches to validation The validation life cycle Maintenance and Cleaning of Drug Manufacturing Equipment (PHA44) Properly designed, constructed, cleaned, and maintained equipment lies at the core of the process control necessary to consistently manufacture pure, high quality drug products. In this interactive program you assume the role of the new manager of the Engineering Department. You will be involved in equipment selection, installation, qualification, and maintenance. Upon completing this lesson, learners will be able to describe cleaning and maintenance practices for equipment used in manufacturing, as well as how a pharmaceutical company incorporates this equipment in their manufacturing. Additionally, learners will be able to identify the necessary documentation and records for equipment used in the manufacture of prescription and over-thecounter drugs. 60 GMPS for equipment design and construction Objectives for equipment maintenance and cleaning Equipment validation GMP requirements for identifying equipment GMP requirements for equipment records * Also available for Personal Care Products Industry: Course PC02 Managing FDA Inspections for Pharmaceutical Manufacturers (PHA66) This course reviews effective measures for managing FDA inspections of pharmaceutical drug manufacturing facilities. The measures reviewed include preparation, interaction, handling, and follow-up. After completing this course, you will be able to identify various industry practices that are essential for managing FDA inspections effectively, including preparation before an inspection, elements of an FDA Inspection Guide, protocol for interacting with FDA, ending an inspection, and following up after the inspection.

How to prepare for an FDA inspection Key areas of the Inspection Guide Systems covered in the System-based Approach FDA Interaction Inspection Conduct How to close-out an FDA inspection Follow-up Medical Device Packaging, Labeling, and Distribution (DEV41) Mistakes or mix-ups in the critical areas of product packaging, labeling, and distribution can pose a danger to the consumer. This course provides you with information on current packaging and labeling requirements specified by the Quality System Regulation. A basic understanding of quality system regulations for medical device and equipment manufacturers (21 CFR 820), quality control procedures, and quality principles is a perquisite for this course. 61 What is medical device labeling? Safe and effective labeling, and misbranding Label control Proper packaging procedures Distribution requirements for devices GMP Training Requirements (PHDV76) In order to produce products that are pure, safe, effective, and in compliance with FDA regulations, it is necessary to understand the nature of GMP Training Requirements. GMP regulations are very clear as to what training is required. This interactive program introduces you to these training requirements and asks you to apply them to actual FDA-regulated industry situations. Upon completion of this lesson, you will be able to discuss the requirements and different types of training specified in GMPs. You will also be able to discuss several varied approaches to training and understand the advantages and disadvantages of each. Finally, you will understand the more technical aspects of training, why each is important to GMP compliance, and identify examples of

achieving training compliance. GMP training requirements Types of GMP training Approaches to GMP training Training verification Meeting Process Requirements for Returned and Salvaged Drug Products (PHA42) Learn the specific requirements set forth in the Good Manufacturing Practice Regulations (GMP s) to assure the purity, safety, and effectiveness of returned and salvaged drugs when they are deemed suitable for distribution. This program examines the relationship of product complaints and investigations to drug products that have been returned or salvaged, and how these may impact what can be done with such drug products. This program addresses the unique principles and practices involved in proper handling and processing of returned and salvaged products, GMP requirements, acceptable practices and procedures, and documentation are included in the lesson. 62 Returned and salvaged drug products Procedures for processing returned and salvaged products Evaluating returns for resale Products that can be salvaged Documentation requirements for returned and salvaged products Orientation to GMP Compliance (PHDV73) Many people, including those who work in the drug and medical device industries, find regulations confusing. Because FDA regulations have a direct impact on how you do your job, this interactive program is designed to take the mystery out of these regulations by giving you insight on how they are applied and interpreted. You will better understand how the FDA and your own company s compliance professionals interpret and apply these important regulations. Upon completion of this lesson you will be able to explain how the Food, Drug, and Cosmetic Act are tied to the Code of Federal Regulations Title 21, and how the GMPs are key elements in those regulations. In addition, you will understand how various FDA publications aid in interpreting and determining the FDA s expectations in regards to these regulations.

What regulations are The goal of GMP regulations Interpreting the regulations Enforcing regulations Packaging and Labeling of Finished Pharmaceuticals (PHA39) This course examines the packaging and labeling of pharmaceutical products. Included is a discussion on the importance of these activities, possible impact of mix-ups that can occur with packaging or labeling, and the controls for these activities required by the cgmp regulations. In addition, typical approaches taken with packaging to protect consumers are reviewed. After completing this course, you will be familiar with GMP requirements for packaging and labeling, and the systems and procedures that prevent mix-ups. GMP principles for packaging and labeling Primary and secondary packaging Consumer protection Preventing packaging mix-ups Proper product labeling Label control prior to production On-line controls used during production 63 Packaging and Labeling of Finished Pharmaceuticals (PHA39-EU) This course examines the packaging and labeling of pharmaceutical products. Included is a discussion on the importance of these activities, possible impact of mix-ups that can occur with packaging or labeling, and the controls for these activities required by the cgmp regulations. In addition, typical approaches taken with packaging to protect consumers are reviewed. After completing this course, you will be familiar with GMP requirements for packaging and labeling, and the systems and procedures that prevent mix-ups. GMP principles for packaging and labeling Primary and secondary packaging Consumer protection

Preventing packaging mix-ups Proper product labeling Label control prior to production On-line controls used during production Part 11: Electronic Records and Signatures Changes in Enforcement Policy (FDA57) This course will provide the learner with an understanding of the change in enforcement policy of FDA for 21 CFR Part 11, Electronic Records; Electronic Signatures. The course discusses the Guidance for Industry; Part 11, Electronic Records; Electronic Signatures Scope and Application, August 2003. 64 Part 11 Basic requirements for electronic records Security requirements for electronic records Basic requirements for electronic signatures Controls for electronic signatures FDA enforcement of Part 11 Note: This course was created by EduNeering in collaboration with EduQuest, Inc. Part 11: Electronic Records; Electronic Signatures (FDA31) The principle purpose of 21 CFR Part 11 is to ensure that when electronic records and signatures are used, they meet the minimum requirements of trustworthiness, reliability, and compatibility with FDA s mission of public health and safety. This interactive lesson is designed to introduce you to the regulatory requirements for electronic records and electronic signatures, as well as FDA expectations for compliance. You will learn specific Part 11 requirements that govern the use of electronic records and signatures as well as FDA enforcement of Part 11. Part 11 Basic requirements for electronic records

Security requirements for electronic records Basic requirements for electronic signatures Controls for electronic signatures FDA enforcement of Part 11 Note: This course was created by EduNeering in collaboration with EduQuest, Inc. Pre- and Post-Approval FDA Inspections (PHDV66) This lesson explores pre- and post-approval FDA inspections. The purpose and focus of each type of inspection are discussed with the key inspectional targets. For pre-approval inspections, the discussion focuses on the process and documentation related to demonstrating equivalence of the bio-clinical batches, raw materials, manufacturing process, finished product, and general GMP compliance. For post-approval inspection, discussion focuses on general GMP compliance issues. For each type of inspection, the various inspection outcomes are also covered. Because all FDA-regulated facilities will undoubtedly be subject to FDA inspection, it is important that employees understand what to expect and what their role should be. When this lesson is completed, the learner will be able to discuss the differences between pre- and post-approval FDA inspections, why they occur, and possible outcomes of each. 65 Pre-approval inspections Focus of PAI Post-approval inspections Reasons for post-approval inspections Possible FDA inspection outcomes Preventing Microbial Cross-Contamination (FOOD3) The inadvertent transfer of potentially harmful microorganisms from raw to finished processing areas can result in contaminated end product and foodborne disease. In the food plant, preventing microbial cross-contamination is everyone s responsibility. After completing this course, learners will understand potential sources of cross-contamination and ways they can help prevent it.

Definition of microorganisms Movement of raw materials and microorganisms How employees can cause contamination How equipment can cause contamination if not handled and stored properly Identification of other sources of contamination Principles of Aseptic Processing (PHDV71) Because microbiological (bacteria, molds and fungi) and particulate contamination can potentially cause serious health problems in animals and humans it is vital that sterile products be manufactured, filled and packaged in a aseptic environment. This lesson will address the general principles and practices necessary to assure product sterility and safety related to aseptic processing. It will also address the principles of Good Manufacturing Practice Regulations (GMPs) as they apply to aseptic processing. 66 Aseptic processing Controlling the aseptic processing environment Employee requirements for aseptic processing Preparing components for sterile products Media fill Environmental monitoring programs Principles of Aseptic Processing (PHDV71-EU) Because microbiological and particulate contamination can potentially cause serious health problems in animals and humans, it is vital that sterile products be manufactured, filled, and packaged in an aseptic environment. This course will address the general principles and practices necessary to assure product sterility and safety related to aseptic processing. It will also address the principles of Good Manufacturing Practice (GMP) for aseptic processing as required by both the European Union (EU) and FDA.

Aseptic processing Controlling the aseptic processing environment Employee requirements for aseptic processing Preparing components for sterile products Media fill Environmental monitoring programs Principles of Good Documentation (PHDV65-EU) Documentation is an important aspect of Good Manufacturing Practice (GMP). This course provides an overview of the importance of documentation, batch records, procedures, and testing throughout the manufacturing process. Following established practices allows everyone who reads your documentation to understand exactly what you mean. After completing this course, you will recognise the importance of good documentation practices. You will also be able to identify acceptable documentation practices and common forms of documentation used during the manufacturing process. The course covers requirements of the European Union (EU) and FDA. 67 Good documentation practices Documenting weights Documents required by the GMPs Proper documentation within a batch production record Documenting laboratory and inspection records Principles of Sterilisation (PHDV81-EU) This course discusses the basic principles of several commonly used sterilisation techniques: moist-heat, dry-heat, gas, radiation, chemical, and filtration. It also provides an introduction to the microbiology involved in producing a sterile product. Finally, the key aspects of sterility assurance are discussed. Moist Heat Dry Heat Chemical Sterilisation Gas Sterilisation Filtration

Sterility Assurance Principles of Auditing (PHDV69) This program focuses on the purpose and conduct of internal and external quality audits. It discusses the purpose of conducting audits, and focuses on the benefits to be derived if audits are conducted properly. It begins with a discussion on establishing an audit program to achieve internal GMP compliance. The program of the lesson is on the actual preparation, conduct, and follow-up associated with an internal audit. Finally, the importance of establishing corrective action and follow-up and how these aspects of the audit program can yield opportunities and quality improvements will be illustrated. At the conclusion of this program, you will be able to discuss the importance of an effective audit program, the benefits that can result, actual conduct of an audit, and how proper corrective action and follow-up yield the ultimate benefits of the program. 68 Audits Types of audits Benefits of performing an audit Preparing for an audit Performing an audit Audit closeout

Principles of Cleaning Validation (PHA37) The cleaning of equipment used in a pharmaceutical operation can be a complex process. Even the smallest amount of chemical residual material in equipment can be extremely dangerous even deadly. It is for these reasons that FDA enhanced cleaning requirements for pharmaceutical manufacturers. In this course you will learn the basics of cleaning validation in pharmaceutical manufacturing operations. The lesson will focus on cleaning procedures and the development of methods and approaches to validating your processes, and how to assess clean and developing methodologies for sampling and analyzing chemical residuals. Cleaning validation Choosing the proper cleaning method Why a cleaning Standard Operating Procedure is necessary Assessing clean Testing for chemical residues Proving methods Acceptance limits Testing and monitoring the cleaning procedures Control and monitoring procedures 69 Principles of FDA Inspections for Pharmaceutical Manufacturers (PHA61) This course reviews the basics of FDA inspections of drug manufacturing facilities, including authority, purpose, types, and areas/operations typically inspected. The course also reviews how companies and their personnel should generally handle FDA inspections and interact effectively with Investigators. After completing this course, you will be able to identify the basics of FDA inspections of drug

manufacturing facilities, including authority, purpose, types, and areas/operations typically inspected. You ll also identify how firms should handle FDA inspections & interact effectively with Investigators. Scope of FDA inspections Types of inspections How inspections are initiated Guidance for handling inspections Areas FDA will likely inspect Interacting with FDA What happens at the end of an inspection 70 Principles of Good Documentation (PHDV65) Documentation is an important aspect of Good Manufacturing Practices (GMPs). This course provides an overview of the importance of documentation, batch records, procedures, and testing throughout the manufacturing process. Good documentation practices Documenting weights Documents required by the GMPs Proper documentation within a batch production record Documenting laboratory and inspection records Note: This course is also available in Spanish and French. Principles of Good Documentation (PHDV65-EU) Documentation is an important aspect of Good Manufacturing Practice (GMP). This course provides an overview of the importance of documentation, batch records, procedures, and testing throughout the manufacturing process. Following established practices allows everyone who reads your documentation to understand exactly what you mean. After completing this course, you will recognise the importance of good documentation practices.

You will also be able to identify acceptable documentation practices and common forms of documentation used during the manufacturing process. The course covers requirements of the European Union (EU) and FDA. Good documentation practices Documenting weights Documents required by the GMPs Proper documentation within a batch production record Documenting laboratory and inspection records Principles of Sterilisation (PHDV81-EU) This course discusses the basic principles of several commonly used sterilisation techniques: moist-heat, dry-heat, gas, radiation, chemical, and filtration. It also provides an introduction to the microbiology involved in producing a sterile product. Finally, the key aspects of sterility assurance are discussed. Moist Heat Dry Heat Chemical Sterilisation Gas Sterilisation Filtration Sterility Assurance 71 Principles of Sterilization (PHDV81) This course discusses the basic principles of several commonly used sterilization techniques: moist-heat, dry-heat, gas, radiation, chemical, and filtration. It also provides an introduction to the microbiology involved in producing a sterile product. Finally, the key aspects of sterility assurance are discussed. After completing this course, you will be able to define sterilization and list the most common sterilization methods. You will also be able to recognize the general approaches for validating and monitoring sterilization processes, and identify the key aspects of sterility assurance.

Sterilization Moist-heat (or steam) sterilization Dry-heat sterilization Gas sterilization (Ethylene oxide) Radiation sterilization Chemical sterilization Filtration sterilization Sterility assurance Public Health Principles (FDA36) 72 This course introduces the learner to the concept of public health and its principles. It explores the history of public health, as well as the definitions of terms crucial to the public health concept. This course also explores the chain of events that leads to disease, the means of transmission, and ways to control disease. Defining Public Health The Public Health Field Health Services Chain of Events Transmissible Methods Disease Control Q10 Pharmaceutical Quality System (ISPE11) This course describes a model for an effective quality management system for the pharmaceutical industry. The course is based on guidance developed by the ICH. The guidance is supported by the Food and Drug Administration (FDA) and is representative of their current thinking on this topic.

TOPICS: Enablers Management Product Lifecycle Process Performance CAPA and Change Management Review Improvement Regulatory Q9: Quality Risk Management (ISPE09) This course introduces the principles of quality risk management (QRM) developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This course explores the definition of QRM and the basic steps of a typical QRM process. Risk management tools will also be associated to the appropriate steps of the QRM process to further comprehend how to effectively handle QRM throughout the lifecycle of a product. TOPICS: 73 QRM Process Tools Applying QRM

QS Regulation 1: Overview and General Provisions (QSR01) This course introduces the Quality System (QS) Regulation (21 CFR Part 820)--a framework of basic requirements for manufacturers of finished medical devices. The course covers the history of the regulation, as well as its requirements, scope, and key terms. The course also discusses the manufacturer s responsibility for a quality system under this regulation. QS Regulation 10: Servicing; Statistical Techniques (QSR10) The tenth in a series of Quality System (QS) Regulation courses, this course focuses on Servicing (21 CFR Part 820 Subpart N) and Statistical Techniques (21 CFR Part 820 Subpart O). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. Statistical techniques may be employed to fulfill a number of QS Regulation requirements. Where statistical techniques are used, manufacturers must establish procedures for identifying valid statistical techniques. 74 After completing this course, you will be familiar with a manufacturer s responsibilities relative to the servicing and statistical techniques requirements of the QS Regulation Learners should complete the previous courses in the series before taking this course. Key Terms Servicing Requirements Analysis Statistical Techniques QS Regulation 11: Application and Inspection of QS Regulation (QSR11) This is the eleventh and final course in the series of Quality System (QS) Regulation courses. The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. This course focuses on the application and inspection of Quality System Regulation requirements within a medical device manufacturer s quality system. During inspections, FDA will assess whether a manufacturer has established procedures and followed requirements that are appropriate to a given device under the current state-of-the-art manufacturing for the specific device.

After completing this course, you will be familiar with the application and interrelationship of QS Regulation requirements within a medical device manufacturer s quality system. You will also be familiar with the basic concepts of the Quality System Inspection Technique (QSIT), which is the inspection process currently used by the FDA to conduct Level 2 Baseline (Comprehensive) quality system inspections Learners should complete the previous courses in the series before taking this course. Key Terms Seven Subsystems Subsystems and QSIT QS Regulation 2: Quality System Requirements (QSR02) The second in a series of Quality System Regulation courses, this course focuses on the management responsibility, quality auditing, and personnel requirements of 21 CFR Part 820, Subpart B. The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. Learners should complete QS Regulation 1: Overview and General Provisions before taking this course. 75 QS Regulation 3: Design Controls (QSR03) The third in a series of Quality System Regulation courses, this course addresses design controls requirements of the Quality System Regulation. Learners should complete QS Regulation 1: Overview and General Provisions and QS Regulation 2: Quality System Requirements before taking this course. Content for this course was provided by ISPE and reviewed by the US Food and Drug Administration as a result of a CRADA between EduNeering, Inc. and FDA QS Regulation 4: Document and Purchasing Controls (QSR04) The fourth in a series of Quality System Regulation (QS Regulation) courses, this course focuses on the Document Controls requirements of 21 CFR Part 820, Subpart D and the Purchasing

Controls requirements of 21 CFR Part 820, Subpart E. The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. Learners should complete QS Regulation 1: Overview and General Provisions, QS Regulation 2: Quality System Requirements, and QS Regulation 3: Design Controls before taking this course. QS Regulation 5: Identification and Traceability; Production and Process Controls (QSR05) The fifth in a series of Quality System (QS) Regulation courses, this course focuses on Identification and Traceability (21 CFR Part 820, Subpart F) and Production and Process Controls (21 CFR Part 820 Subpart G). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. The purpose of the Production and Process Controls requirements of the QS Regulation (21 CFR 820.70, 21 CFR 820.72, 21 CFR 820.75) is to ensure that manufacturers produce devices that conform to their specifications. Where any deviations from specifications could occur during manufacturing, process control procedures must describe the controls necessary to ensure the devices will conform to their specifications. Process control procedures also help to ensure consistency in manufacturing. 76 After completing this course, you will be familiar with a manufacturer s responsibilities relative to the Identification and Traceability, and Production and Process Controls requirements of the QS Regulation. Learners should complete the previous courses in the series before taking this course. QS Regulation 6: Acceptance Activities; Nonconforming Product (QSR06) The sixth in a series of Quality System (QS) Regulation courses, this course focuses on Acceptance Activities (21 CFR Part 820 Subpart H) and Nonconforming Product (21 CFR Part 820 Subpart I). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. Learners should complete the previous courses in the series before taking this course. QS Regulation 7: Corrective and Preventive Action (QSR07) The seventh in a series of Quality System (QS) Regulation courses, this course focuses on Corrective and Preventive Action (21 CFR Part 820 Subpart J). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. The intent of 21 CFR 820.100 is to correct or prevent poor practices, not simply to correct or prevent bad product. Correction and prevention of unacceptable quality system practices should result in fewer nonconformities related to product. Compliance with the corrective and preventive action requirements of the Quality System (QS) Regulation will allow a firm to monitor, identify, and react to existing product and quality system problems, as well as indicators of potential problems. These activities will help manufacturers

identify opportunities to improve their products and quality system, as well as protect consumers by initiating field actions where necessary. After completing this course, you ll be familiar with a manufacturer s responsibilities relative to the corrective and preventive action requirements of the QS Regulation. Learners should complete the previous courses in the series before taking this course. QS Regulation 8: Labeling and Package Control; Handling, Storage, Distribution, and Installation (QSR08) This course is the eighth in a series of Quality System (QS) Regulation courses. This course focuses on Labeling and Package Control (21 CFR Part 820 Subpart K) and Handling, Storage, Distribution, and Installation (21 CFR Part 820 Subpart L). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. The requirements of the QS Regulation relative to the Handling, Storage, Distribution, and Installation of medical devices are intended to help ensure that medical device mixups, damage, deterioration, contamination, or other adverse effects do not occur. After completing this course, you will be familiar with a manufacturer s responsibilities relative to the labeling, packaging control, handling, storage, distribution, and installation requirements of the QS Regulation. Learners should complete the previous courses in the series before taking this course. 77 Key Terms Label Integrity Labeling Operations Handling/Storage Areas Control & Distribution Device Installation QS Regulation 9: Records (QSR09) The ninth in a series of Quality System (QS) Regulation courses, this course focuses on Records (21 CFR Part 820 Subpart M). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. One of the basic themes of the Quality System Inspection Technique (used during inspections of medical device manufacturers) is the Establish Test. The QS Regulation requires many procedures to be established and defines establish as define, document (in writing or electronically), and implement. Records play a vital role in FDA s ability to confirm that procedures have been appropriately implemented and, on a broader scope, that an adequate and effective quality system has been established and maintained by the firm being inspected. After completing this course, you will be familiar with a manufacturer s responsibilities relative to the records requirements of the QS Regulation.

Learners should complete the previous courses in the series before taking this course. General Requirements Device Master Records Device History Records Quality System Records Complaint Records Investigations Complaint Unit 78 Quality Systems Approach (ISPE10) FDA is continuing to modernize its approach to GMP for pharmaceuticals and biologics, as initially outlined under the CGMPs for the 21st Century initiative. This course explains the basis for this significant shift in FDA s regulatory approach to manufacturing practices, outlines what it means for the regulated industries, and provides examples of actions that FDA has already taken to implement its quality systems expectations. TOPICS: CGMP Overview Quality Concepts Quality System Quality Systems Model Resources Manufacturing Quality Evaluation Requirements for Computerized Systems Validation and Compliance (ISPE01) This course, the first in a four-part series, describes regulatory requirements and expectations regarding the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices. It does not cover the detailed requirements of 21 CFR Part 11, except the requirement for systems to be validated. Even though it draws upon medical device guidance, it is not intended to cover all the requirements of producing software that subsequently becomes part of a medical device.

Computerized or automated systems Regulations addressing the requirements for validating computerized systems Three types of validation How software differs from hardware Guiding principles for computerized systems validation and compliance IQ, OQ, and PQ as related to computerized systems validation FDA s expectations for validation activities and documentation Note: Content for this course is provided by the International Society of Pharmaceutical Engineers (ISPE) and reviewed by the US Food and Drug Administration as a result of a CRADA between EduNeering and FDA. Resolving Out of Specification Test Results (PHA50) Obtaining an out of specification test result can be unsettling, and it is important that you know what to do with it. You will learn what the FDA says about handling batch or product samples that indicate out of specification results. You will also learn how to evaluate suspect results as well as how to conduct preliminary investigations in response to OOS results. This lesson will provide you with the information to respond accordingly when an OOS result is encountered. Mastering this content will enable you to know what to look for and what to investigate when an OOS result occurs. It will also explain the cautions involved in handling data that may be related to OOS results, such as re-testing, averaging, and outliers. 79 Out of specification (OOS) test results Purpose of a laboratory investigation Performing a formal investigation

Use of averaging Outliers What is required when an OOS result is determined to be valid * Also available for Personal Care Products Industry: Course PC06 Review of Basic Statistical Techniques (DEV44) This course will explore the proper use of statistical techniques as they apply to medical device manufacturing. More than just a set of mathematical tools, the use of statistics in medical device manufacturing is now expected and regulated by the Food and Drug Administration in the Quality System Regulation, Subpart O, Statistical Techniques. 80 Definition Data Analysis Histograms Variability Safety Trained Supervisor (STS) Test Prep 1 (STS-CERT02) This course explores the Safety Trained Supervisor (STS) certification exam. The questions in this test prep are based on questions that you will see in the STS exam. Safety Trained Supervisor (STS) Test Prep 2 (STS-CERT03) This course explores the Safety Trained Supervisor (STS) certification exam. The questions in this test prep are based on questions that you will see in the STS exam. Testing for Bacterial Endotoxins (PHDV86) This course will provide a general overview of bacterial endotoxins and the methods used to test for their presence in products. The specific techniques for conducting the gel-clot LAL test will be presented, including extensive discussion on standards and controls used. In addition, variations to the gel-clot test will be presented, including the chromogenic and kinetic alternatives, along with the advantages and disadvantages of each method. Bacterial endotoxins

Performing the gel-clot LAL test Chromogenic LAL assay Determining appropriate testing methods The Design and Development of Software Used in Automated Process Controls (PHDV80) Both the pharmaceutical and medical device industries automate their manufacturing processes in order to make them more efficient, more accurate, and more consistent. As a result, the use of computerized systems in the pharmaceutical and medical device industry has become common. This lesson serves as an introduction to the design and development of process control software. Compliance requires that manufacturers apply the principles and practices of software quality assurance to automated systems that may ultimately affect product safety and effectiveness. At the conclusion of this module you will be able to explain the software development lifecycle, including basic verification and validation activities, and describe several aspects of software quality assurance, including training and qualification of vendors. Automated process controls Types of software used to automate processes Software requirements Design implementation and development Software verification and software validation Final two phases of the Software Development Life Cycle 81 Traceback Investigations 1: Introduction (TI01) This course explains the purpose of a traceback investigation in a foodborne illness outbreak investigation. The course provides guidance on the types of data needed by FDA to determine if a traceback investigation will be initiated and where to obtain the data. In addition, the course gives an overview of investigative techniques for communicating with a firm during a traceback investigation. Traceback Investigations 2: Point-of-Service Investigations (TI02) This course will explain the procedures for conducting a traceback investigation at the Point-of-Service (POS). The course provides information on the types of records that the

investigator will collect and review, as well as the information he or she should gather during interviews with the employees. Finally, it introduces the analysis tools used by FDA Emergency Operations to analyze and communicate traceback data. This course is also available in Spanish and Canadian French. Traceback Investigations 3: Distributor Investigations (TI03) This course will explain the procedures for continuing a traceback investigation at distributors identified during the POS investigation. The course provides information on the types of distributors that may be investigated, the records the investigator will collect and review, as well as the information he or she should gather during interviews with the employees. Finally, it further explains and expands on the tools FDA Emergency Operations will use to analyze and communicate distributor data. Prerequisites for this course include the Food Microbiological Control series (recommended); the Foodborne Illness Investigation series (required); Traceback Investigations 1: Introduction; and Traceback Investigations 2: Point-of-Service Investigations.Traceback Investigations 4: 82 Traceback of Eggs and Other Commodities (TI04) This course provides historical and biological explanations of the association of shell eggs with Salmonella contamination. This course focuses on the unique aspects of tracing back shell eggs and packaged foods. Finally, this course provides an outline to help distinguish the jurisdiction for certain commodities that FDA may be requested to investigate and traceback. Prerequisites for this course include Food Microbiological Control series (recommended); the Foodborne Illness Investigation series (required); Traceback Investigations 1: Introduction; Traceback Investigations 2: Point-of-Service Investigations; and Traceback Investigations 3: Distributor Investigations. Concluding the Investigation and Reporting the Results (TI05) This course will explain to you the different types of communications used in a traceback investigation report and their importance to the investigation. Each day spent tracing and identifying a food product is an additional day that the product may still be in the marketplace and be a hazard to consumers. In most cases of foodborne outbreaks linked to fresh produce, the product is no longer available by the time the outbreak is detected and a food is implicated. However, the conditions which existed that caused the outbreak may still be occurring and they may cause or contribute to additional outbreaks in the future. Most FDA inspections allow for a period of time, such as 30 days to complete your final written inspection report. In FDA, the goal is to complete the entire traceback investigation in less than 30 days. The average traceback investigation may include visits to 10 or more firms. An oral report allows for immediate data

analysis, which in turn is confirmed by a written summary. The next assignment can then be rapidly issued, in many cases the very same day. A final written report is still expected and can be submitted under the same guidelines and time frame as an inspection. Understanding GMPs for Facilities and Equipment (PHDV63) Facilities and equipment GMP requirements impact many aspects of plant operation from setup to maintenance and cleaning. This interactive program introduces the general layout and equipment used within a pharmaceutical or medical device manufacturing plant. GMP regulations General GMP requirements for facilities Requirements for the cleanliness of facilities Design of facilities to promote proper flow Equipment requirements Equipment maintenance Equipment calibration 83 Note: This course is also available in French. Understanding Post-Approval Changes (PHA49) This course covers the definition and purpose of post-approval changes. In addition, it explores the four categories of change: Components and Composition, Scale of Manufacture, Site of Manufacture, and Manufacturing, and requirements for each level of change. You will learn about PAC guidance and how these documents are used to provide notification to FDA for post-approval changes to an approved drug application. You will examine the levels of PAC and the recommended chemistry, manufacturing, and control (CMC) requirements for each level. You will also explore the categories of change. Finally, you will be able to identify the tests and documents needed for each level and category of change. Defining post-approval changes PAC guidance documents SUPAC guidance Components and Composition category Site of Manufacture category Scale of Manufacture category

Manufacturing category Understanding the GMP Requirements for Facilities and Equipment (PHDV63-EU) Facilities and equipment GMP requirements impact many aspects of plant operation from setup to maintenance and cleaning. This interactive programme introduces the general layout and equipment used within a pharmaceutical or medical device manufacturing plant. The course covers requirements of the European Union and FDA. 84 Facilities Cleanliness Process Flow Equipment Maintenance Calibration Cleaning Understanding the Principles and Practices of Process Controls (PHA47) Recently FDA has become increasingly concerned with the number of Warning Letters being issued due to problems with the control of manufacturing processes. Items listed in these various Warning Letters include lack of validation of manufacturing processes, lack of written procedures, improper sampling and testing of materials, and failure to follow written procedures. This course provides an understanding of what process control is. You will also learn about the written procedures involved in validation, how equipment affects process controls, batch production records, correct sampling and testing methods, proper reprocessing techniques, contamination control, and change control.

Validation Equipment s affects on process controls Batch production record Sampling and testing Reprocessing Contamination control Change control Validation of Analytical Laboratory Procedures (ISPE08) This course introduces developers and those individuals involved in validation of analytical methods to the regulatory requirements for the validation of analytical laboratory procedures. After taking this course, you will be able to identify the purpose and benefits of validation, determine when validation is necessary, and recognize common approaches to these activities. TOPICS: Validating Processes Specificity Linearity and Range Accuracy and Precision Detection/Quantitation Robustness Revalidation 85 Vendor Certification for Pharmaceutical Manufacturers (PHDV85) This course discusses the process of vendor certification a means of ensuring that a company is receiving the best possible materials, products, and services from its vendors or suppliers. This course covers the common practices and concepts associated with vendor certification. After completing this course, you will have a basic understanding of the value and process of vendor certification Vendor certification process Criteria for selecting vendors for certification Vendor audits Testing

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