LIBRARY GUIDE. Online Courses. September 2011

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1 LIBRARY GUIDE Online Courses September 2011 i

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

4 Table Online of Contents Courses (Continued) iv Dietary Supplements CGMPS for Manufacturing Plants and Equipment (Dietary 03) Dietary Supplements - Introduction to Part 111 CGMPs (Dietary 02) Dietary Supplements Packaging, Labeling, Holding, and Distribution (Dietary 01) Dietary Supplements Production and Process Control System for Manufacturing Operations (Dietary 04) Dietary Supplements Requirements for Records and Recordkeeping (Dietary 06) Documenting the Drug Development Process (ICHQ8) (ISPE07) Documenting Validation Activities (PHA55) Effectively Responding to FDA 483s and Warning Letters (PHDV70) Emergency Preparedness and Response (FDA49) Employee Hygiene: Food Service (FOOD1) Environmental Control and Monitoring (PHDV87) Environmental Control and Monitoring (PHDV87-EU) Essentials of an Effective Calibration Program (PHDV75) EU Medical Device Directive Part II: Specific Procedures (MDD02) EU Medical Device Directive Part I: Introduction (MDD01) Failure Investigations for Medical Device Manufacturers (DEV45) Failure Investigations for Pharmaceutical Manufacturers (PHA59) Failure Investigations for Pharmaceutical Manufacturers (PHA59-EU) FDA Regulated Product Labeling (FDA44) FDA Training and Qualification Requirements (PHA67) Food Code Chapter 1 (FDAFC02) Food Code Chapter 3: Part I (FDAFC03) Food Code Chapter 3: Part II (FDAFC05) Food Code Chapter 3: Part III (FDAFC06) Food Code Chapter 5: Water, Plumbing, and Waste (FDAFC04) Food Code Chapter 7: Poisonous and Toxic Materials (FDAFC01) Food Labeling (FDA45) Food Microbiological Control 1: Overview of Microbiology (MIC01) Food Microbiological Control 10: Aseptic Sampling (MIC13) Food Microbiological Control 11: Good Manufacturing Practices (MIC14) Food Microbiological Control 12: Cleaning and Sanitizing (MIC15) Microbiological Control 2A: Gram -Negative Rods (MIC02) Negative Rods and Cocci (MIC03) Food Microbiological Control 3: Foodborne Viruses (MIC04) Food Microbiological Control 4: Foodborne Parasites (MIC05) Food Microbiological Control 5: Controlling Growth Factors (MIC06) Food Microbiological Control 6: Control by Refrigeration and Freezing (MIC07) Food Microbiological Control 7A: Control by Thermal Processing (MIC08) Food Microbiological Control 7B: Control by Pasteurization (MIC09) Food Microbiological Control 7C: Control by Retorting (MIC10)

5 Table Online of Courses Contents (Continued) Food Microbiological Control 8: Technology-based Food Processes (MIC11) Food Microbiological Control 9: Natural Toxins (MIC12) Food Microbiological Control: Mid-Series Exam (MIC16) Foodborne Illness Investigations 1: Collecting Surveillance Data (FI01) Foodborne Illness Investigations 2: Beginning an Investigation (FI02) Foodborne Illness Investigations 3: Expanding the Investigation (FI03) Foodborne Illness Investigations 4: Conducting a Food Hazard Review (FI04) Foodborne Illness Investigations 5: Epidemiological Statistics (FI05) Foodborne Illness Investigations 6: Final Report (FI06) Global Anti-Bribery: UK (RH0041-UK) Principles for Batch Records (PHA60) GMP Principles of SOPs (PHA64) GMP Updates -- Enforcement Changes at the New FDA (PHDV91) GMPs for API Bulk Manufacturers (PHA52) Gowning for Sterile Manufacturing (PHA63) Gowning for Sterile Manufacturing (PHA63-EU) GxPs (PHDV61) HACCP (FOOD4) Handling a Product Recall (PHDV64) Handling an FDA Inspection (PHDV74) High Purity Water Systems (PHDV82) How to Meet Drug Retention and Stability Testing Requirements (PHA43) ICH Q7A: Introduction and Quality Management (ISPE05) ICH Q7A: Resources and Materials Management (ISPE06) Implementing an Equipment Qualification Program (PHDV88) Interviewing Techniques (FDA27) Introduction to GMPs (PHA38) Introduction to Quality System Regulations (QSR) (DEV43) Key Concepts of Process Validation (PHDV77) Maintenance and Cleaning of Drug Manufacturing Equipment (PHA44) Managing FDA Inspections for Pharmaceutical Manufacturers (PHA66) Medical Device Packaging, Labeling, and Distribution (DEV41) GMP Training Requirements (PHDV76) Meeting Process Requirements for Returned and Salvaged Drug Products (PHA42) Orientation to GMP Compliance (PHDV73) Packaging and Labeling of Finished Pharmaceuticals (PHA39) Packaging and Labeling of Finished Pharmaceuticals (PHA39-EU) Part 11: Electronic Records and Signatures Changes in Enforcement Policy (FDA57) Part 11: Electronic Records; Electronic Signatures (FDA31) Pre- and Post-Approval FDA Inspections (PHDV66) Preventing Microbial Cross-Contamination (FOOD3) Principles of Aseptic Processing (PHDV71) Principles of Aseptic Processing (PHDV71-EU) Principles of Good Documentation (PHDV65-EU) v

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

7 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 addresses of each learner. Those learners will be notified via 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.

8 Course Descriptions (Listed Alphabetically) A Guide to ISO The Quality Management System for Medical Devices (DEV50) This course is designed to describe the basic requirements for ISO 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.

9 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

10 An Introduction to ISO The Quality Management System for Medical Devices (DEV48) In this course, you will be able to identify why ISO 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 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. Topics Include: 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

11 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

12 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

13 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.

14 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.

15 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

16 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

17 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

18 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

19 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. Topics Include: 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 Registration of Food Facilities.

20 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. Topics Include: 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.

21 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 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 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

22 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

23 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

24 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. 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.

25 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

26 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

27 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

28 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 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, 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

29 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

30 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

31 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 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

32 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

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