Catalog. Global Education. and Training. Global Expertise Trusted Standards Improved Health

Transcription

1 Global Education Catalog and Training Global Expertise Trusted Standards Improved Health

2 USP s mission is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.

3 Table of Contents Why USP Global Education and Training? Convenient Format Options Overview About USP Approved Instructors Registration and Payment Information Courses by Topic Biologics and Biotechnology Dietary Supplements and Food Ingredients Pharmaceuticals General Chapters on Compendial Methods Medication and Patient Safety

4 Why USP Global Education and Training? USP Global Education and Training offers you the unique opportunity to learn how to effectively interpret and apply USP s internationally recognized standards directly from USP and the experts who set them. Only USP courses are guaranteed to have been developed, vetted, and delivered by USP and its experts. Convenient Format Options Classroom: USP offers face-to-face sessions in traditional classroom settings around the world. Engage with experts and peers and get immediate answers to questions. Classroom courses can be customized to your specific needs and delivered at your company location. Laboratory: USP laboratory sessions provide hands-on training in a working laboratory facility. Many courses combine a classroom lecture with a laboratory segment to ensure that you gain comprehensive and practical knowledge of USP standards and how to apply them effectively in your work. Online: USP online courses are designed with flexibility and easy access in mind. Through the Internet from anywhere in the world, you can view interactive presentations, listen to live and/or recorded lectures, and contact USP experts. We offer three types of online courses: Live Webinars allow you to remotely attend live, instructor-led courses. In real time, interact with USP experts and get answers to your questions. Plus, once live webinars are complete, we offer them on-demand and provide you with 30 days additional access. Courses may be offered in multiple formats or in blended learning options (e.g., course with both classroom and lab segments). See individual course descriptions for details. On-demand courses provide immediate and unlimited access to prerecorded webinars and presentations through the Internet for 30 days. Learn at your own pace stop when needed and come back later and pick up where you left off. Self-Paced elearning courses provide an online learning experience that engages students through interactive, scenario-based content, with assessments to check for understanding of key topics. These courses are designed to give students certain control over the time, place, path, and/ or pace of their learning. 4

5 OVERVIEW The U.S. Pharmacopeial Convention (USP) is driven by the mission to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. It s something we ve been doing for nearly 200 years, and, today, our standards are legally recognized in 46 countries and used in more than 140. USP Global Education and Training is integral to fulfilling our mission by providing education and training programs to help scientists, industry professionals, and healthcare practitioners effectively interpret and apply USP standards in their work. To help ensure accuracy and relevance, USP courses are created and approved by USP subject matter experts who volunteer their time and expertise to help establish the standards. Who better to learn USP standards from than the organization and experts who know them best? USP courses are also designed with flexibility, convenience, and regional preferences in mind. We offer face-to-face classroom courses, hands-on laboratory sessions, and interactive on-demand and live webinar online programs. Courses can be customized as well as offered onsite at your location. Since USP s education initiative was launched in 2000, we ve taught more than 29,000 professionals in more than 40 countries around the world! 5

6 ABOUT USP Approved instructors All USP Global Education and Training courses are taught by USP Approved Instructors who have been selected, trained, and approved by USP. Our instructors are chosen for their expertise related to course content and their skills as effective communicators. They are reevaluated annually by USP to maintain their approved status. To learn more about our instructors, see the Instructors insert or visit registration and payment information You can register for USP Global Education and Training Courses in the following ways: Online: Visit choose the course from the interactive calendar, then select Register button. Phone: Call Send questions about registration and courses to USP accepts payment by credit card, wire transfer, or check (U.S. Dollars only and drawn on a U.S. bank). Exact fees are listed with each course on Please note, certain cancellation/substitution, prepayment, inclement weather, and low enrollment policies apply to course registration. For complete details, visit 6 Courses as of July For the latest updates and course information, visit

7 BIOLOGICS AND BIOTECHNOLOGY Classroom Laboratory Online <111> Analysis of Biological Assays (FREE) Course #: B003 Duration: 1 hour Format: Online, on-demand Learn how to interpret and apply USP NF General Chapter <111> Design and Analysis of Biological Assays. Particular attention is given to the biological and statistical considerations in ensuring the reliability of bioassay measurement. <1084> Glycoprotein Glycan Analysis Course #: B001 Duration: 1 hour Format: Online, on-demand Gain insight into the approach that USP is taking toward glycoprotein glycan analysis, based on a combination of qualitative and quantitative standards featured in USP NF General Chapter <1084> Glycoprotein and Glycan Analysis General Considerations and two chapters under development, <210> and <212>. Course also addresses the development of suitable reference standards. Ancillary Materials Used in Cell Manufacturing Course #: B002 Duration: 1 hour Format: Online, on-demand Explore quality aspects and risk assessment strategies applicable to the use of ancillary materials in specific applications such as cell therapies. Learn how the documentary standards and associated reference standards are developed and the importance of setting proper acceptance criteria and specifications for specific cell culture reagents to ensure quality of finished products. Bioassay Validation <1032>, <1033>, and <1034> Course #: A001 Duration: 1 day Format: Classroom Discover the fundamentals of bioassay practices and principles along with associated statistical concepts as featured in USP NF General Chapters <1032> Design and Development of Biological Assays, <1033> Biological Assay Validation, and <1034> Analysis of Biological Assays. Includes tools for statistical and assay design, analysis, and validation needed when developing and performing bioassays. Essentials of Compendial Microbiology Testing Course #: A002 Duration: 2 days Format: Classroom Microbiology is an integral part of developing, processing, and testing finished products, and having a practical understanding of microbiological practices in the pharmaceutical industry is imperative. Through this course, learn about USP NF general chapters that address microbiological testing and how to apply them for quality assurance in your work. Questions? PharmEd@usp.org. 7

8 BIOLOGICS AND BIOTECHNOLOGY Classroom Laboratory Online Heparin Sodium Monograph Test Methods Background and Implementation Course #: A004 Duration: 2 days Format: Classroom Gain an in-depth understanding of how to implement test methods in the recently revised Heparin Sodium monograph specific to the analysis of heparin samples. Designed for lab managers and analysts, this course focuses on equipment, reagents, reference standards, and experimental techniques. To provide context, the recent history of heparin manufacture, scientific literature regarding heparin analysis, background information on structure and function, and underlying principles of the tests will be presented. Introduction to USP Quality Standards for Medicines (FREE) see listing on page 13. In-Vivo In-Vitro Correlation (IVIVC) see listing on page 16. Rapid Microbiological Testing Course #: A005 Duration: 2 days Format: Classroom Learn about microbiological test practices by examining the advantages and disadvantages of classical versus modern/rapid tests, the most common modern/ rapid microbiological methods, and the effective application of compendial and regulatory guidelines. USP Quality Standards for Biologics Course #: B004 Duration: 1 hour Format: Online, on-demand Build upon the introductory course Introduction to Quality Standards for Medicines with this topic-driven course on USP standards and programs specific to biologics and biotechnology. 8 Courses as of July For the latest updates and course information, visit

9 DIETARY SUPPLEMENTS AND FOOD INGREDIENTS cgmps for Dietary Supplements 21 CFR Part 111 (FREE) Course #: B005 Duration: 1 hour Format: Online, on-demand Expand your knowledge of key elements of cgmps per 21 CFR Part 111: personnel, physical plants, equipment, production/process control system, quality control, packaging/labeling, manufacturing batch records, laboratory operations, manufacturing operations, packaging/labeling operations, holding/distribution, and records. Dissolution Testing for Dietary Supplements see listing on page 15. Effectively Using FCC Course #: A006 Duration: 3 hours Format: Classroom Discover how effective use of the FCC, FCC Supplements, and the FCC Forum can benefit your work with food ingredients. In addition, learn about USP the organization behind the FCC and current regulatory recognition of USP standards. Since 2000, we ve taught more than 29,000 professionals in more than 40 countries around the world! Food Chemicals Codex (FCC) Access and Capability (FREE) Course #: B015 Duration: 10 minutes Format: Online, on-demand Learn how to access the FCC. Answers to common questions and information on how to contact USP experts are provided. HPTLC for Identification of Articles of Botanical Origin see listing on page 16. Orthogonal Methods for Identity: Classical Pharmacognosy Coupled with Instrumental Analysis (FREE) Course #: B016 Duration: 1 hour Format: Online, on-demand Learn about the orthogonal methods used in the identification process of botanicals. These methods combine techniques from technological advances with the microscope, chemical spot test, modern separation techniques, highly sensitive detectors, and powerful software packages. Standards for Food Ingredients and Dietary Supplements (FREE) Course #: B006 Duration: 17 minutes Format: Online, on-demand Through this brief overview, become familiar with the Food Chemicals Codex and USP Dietary Supplements Compendium USP s compendia of public standards for the authenticity of food ingredients and dietary supplements. Course includes information on these compendial standards and how they are developed by USP as well as legal recognition. USP NF Fats and Fixed Oils Excipient Monographs and Related Chapters see listing on page 13. Questions? PharmEd@usp.org. 9

10 DIETARY SUPPLEMENTS AND FOOD INGREDIENTS Who better to learn USP standards from than the organization and experts who know them best? USP Perspectives on Dietary Supplements (FREE) Course #: B017 Duration: 20 minutes Format: Online, on-demand Gain insight into USP s work on dietary supplements by exploring the development of standards and information contained in the USP Dietary Supplements Compendium the first reference book containing public standards for dietary supplements. Documentary standards (monographs and general chapters) and information added to the expanded 2012 edition are covered. USP Perspectives on Food Ingredients (FREE) Course #: B026 Duration: 20 minutes Format: Online, on-demand Learn about USP s standards-setting process as it relates to food ingredients and the Food Chemicals Codex USP s compendia containing public standards for food ingredients. Writing Specifications for Dietary Ingredients and Dietary Supplements Using Public Standards Course #: B007 Duration: 1 hour Format: Online, on-demand Learn how to use public standards (e.g., USP NF, FCC, AOAC, Codex Alimentarius, JEFCA) to prepare specifications required by dietary supplement cgmps for incoming raw materials, in-process materials, and outgoing finished goods. Course also addresses requests for proposals to suppliers. 10 Courses as of July For the latest updates and course information, visit

11 Classroom PHARMACEUTICALS Laboratory Online <467> Strategies for Addressing Residual Solvents Course #: B018 Duration: 1 hour Format: Online, on-demand Explore a variety of strategies for demonstrating compliance with residual solvent requirements for drug products specified in USP NF General Chapter <467> Residual Solvents. Strategies include testing using USP procedures, using alternative procedures, and ways to avoid or minimize routine testing. <1079> Updates on Good Storage and Shipping Practices Course #: B019 Duration: 1 hour Format: Online, on-demand See how recent updates to USP NF General Chapter <1079> Good Storage and Distribution Practices for Drug Products can help you implement an optimal Quality Management System for drug products throughout their life cycles as they move through the global supply chain. Learn how proper storage and shipping procedures should be controlled, measured, and also analyzed from point of manufacture to end use or administration to ensure that critical parameters of quality remain intact. <1083> Good Distribution Practices: Supply Chain Integrity Course #: B008 Duration: 1 hour Format: Online, on-demand Listen to presentations and key discussions from the USP Supply Chain Integrity Workshop held May 22 23, Topics include next steps in the development of USP NF General Chapter <1083> Good Distribution Practices Supply Chain Integrity and other supply chain chapters. <1224>, <1225>, and <1226> Validation Verification and Transfer How They Work Together for Analytical Procedures see listing on page 14. Developing Compendial HPLC Industry Practices see listing on page 15. Developing and Validating Dissolution Methods see listing on page 15. Dissolution Apparatus 4 Design, Use, Application, and Suitability see listing on page 15. Dissolution Basics see listing on page 15. Dissolution Performance Verification Testing (PVT) see listing on page 15. Dissolution: Theory and Best Practices see listing on page 16. Effectively Using USP Reference Standards Course #: A007 Duration: 1 day Format: Classroom Gain an in-depth understanding of USP Reference Standards highly characterized chemical specimens required for use in USP NF compendial methods. Course covers types of USP Reference Standards and their practical global applications, as well as information on the science behind their development, specific cases, metrology, and USP support services. Questions? PharmEd@usp.org. 11

12 PHARMACEUTICALS Classroom Laboratory Online Effectively Using USP NF Course #: A008 Duration: 1 day Format: Classroom Learn how the effective use of standards and information in USP NF, USP NF Supplements, and Pharmacopeial Forum can benefit work with drugs and excipients manufactured and distributed around the world. Elemental Impurities An Update (FREE) Course #: B009 Duration: 30 minutes Format: Online, on-demand Make sure you have the latest information on revisions to USP NF General Chapters <232> Elemental Impurities Limits and <233> Elemental Impurities Procedures. Publications, effective, and conformance dates are reviewed. Excipient Performance Course #: A009 Duration: 1 day Format: Classroom Explore excipient function and performance and the role of USP NF General Chapter <1059> Excipient Performance in providing a framework for applying Quality by Design principles. Includes discussion on the link between critical material attributes and drug product critical quality attributes that must be maintained throughout the product life cycle, excipient variability and tools to quantitate and manage it, and recent changes to <1059>. Extractables and Leachables Course #: A010 Duration: 2 days Format: Classroom Be prepared to address increased regulatory concerns regarding extractables and leachables related to the interaction of drug products with various drug product contact surfaces including packaging systems and pharmaceutical process equipment. Learn how to apply current best practices related to the quality and selection of packaging material and testing for extractables and leachables. Good Manufacturing Practices Course #: A011 Duration: 2 days Format: Classroom Gain a sound understanding of principles and requirements of good manufacturing practices for ensuring control of quality attributes of active pharmaceutical ingredients, inactive ingredients, and other products offered for health improvement. Topics include regulatory oversight of manufacturing quality systems and examples of inadequate practices observed in operating factories. How to Access USP NF Information Online (FREE) Course #: B010 Duration: 8 minutes Format: Online, on-demand Learn how to access USP NF information online. Answers to common questions and information on how to contact USP experts are provided. How to Communicate Feedback to USP (FREE) Course #: B011 Duration: 8 minutes Format: Online, on-demand Find out how to communicate feedback to USP and its experts. Answers to common questions are provided. 12 Courses as of July For the latest updates and course information, visit

13 PHARMACEUTICALS How to Use PF Online (FREE) Course #: B020 Duration: 7 minutes Format: Online, on-demand Discover how easy it is to access and use PF Online. Answers to common questions and information on how to contact USP experts are provided. Impurities in Drug Substances and Drug Products A USP Approach Course #: A012 Duration: 2 days Format: Classroom Examine information and case studies on the most recent initiatives on impurities in small molecule drug substances and drug products. Course covers multiple impurity profiles using flexible monograph approach as well as other policies for the control of impurities in official USP articles. Introduction to USP Quality Standards for Medicines (FREE) Course #: B014 Duration: 1 hour Format: Online, on-demand Gain insight into USP s standards-setting process. Learn how USP with the help of stakeholder input and industry support establishes documentary and reference standards for articles in commerce, and how they become eligible for inclusion in the USP NF. All USP courses are taught by USP Approved Instructors who have been selected, trained, and approved by USP. Pharmaceutical Stability Course #: A013 Duration: multiple options available Format: Classroom Learn about essential components for designing global stability programs for pharmaceutical products: regulations, operations, testing, and investigations. Topics include cgmp, USP, FDA, ICH, and WHO stability requirements for establishing expiration dating and label storage criteria; technical and regulatory aspects that may affect design cost-effectiveness and compliance; and stability-indicating methods for monitoring product quality throughout its shelf life. Matrix and bracketing options to reduce testing, stability data evaluation, and investigation of Out-of-Specifications are also addressed. Pharmaceutical Waters Course #: A014 Duration: 2 days Format: Classroom Gain a thorough understanding of current and proposed changes to the compendial and regulatory requirements for waters used in the manufacture and testing of pharmaceuticals. Course covers source water; sterile waters for injections, inhalation, and irrigation; sterile purified water; water for hemodialysis; steam; and systems that produce these waters. USP NF Fats and Fixed Oils Excipient Monographs and Related Chapters Course #: A015 Duration: ½ day Format: Classroom Learn about the development of and recent revisions to USP NF Fats and Fixed Oils excipient monographs and related USP NF General Chapters <401> Fats and Fixed Oils and <1> Injections. Course addresses fat and fixed oil critical quality attributes and how current analytical techniques assess these attributes, as well as how the new and revised standards can help you conform to cgmps, ensure authenticity of excipients, and facilitate utilization of Quality by Design. Validation and Verification of Analytical Procedures see listing on page 17. Questions? PharmEd@usp.org. 13

14 general chapters on compendial methods USP courses are designed with flexibility, convenience, and regional preferences in mind. <1084> Glycoprotein Glycan Analysis see listing on p. 7. <1224>, <1225>, and <1226> Validation, Verification and Transfer How They Work Together for Analytical Procedures Course #: B013 Duration: 1 hour 18 minutes Format: Online, on-demand Get an overview of each chapter and how you can use them together for quality data-acquisition. Topics include definitions and scope of validation, verification, and transfer; when and how to apply each one; and what to do when analysis fails. <1224> Transfer of Analytical Procedures Course #: B022 Duration: 1 hour Format: Online, on-demand Explore the analytical procedure-transfer process and how it is critical to qualifying laboratories that perform analytical procedures developed and validated in other laboratories. USP NF General Chapter <1224> provides guidance on the basic steps and components of a transfer process and summarizes the types of transfers that may occur (including the possibility of waiver). Analysis of Elemental Impurities Course #: A016 Duration: ½ day Format: Classroom Learn about revisions to USP NF General Chapters <232> Elemental Impurities Limits and <233> Elemental Impurities Practices for analysis of elemental impurities in pharmaceutical materials. In addition to highlighting recent changes and the implementation timeline, course covers the elements and how limits are set, how limits apply to products, and a brief method description. Analytical Method Transfer Course #: A034 Duration: 1 hour Format: Online, on-demand Understand how to qualify a laboratory to perform an analytical procedure that was developed and validated in another laboratory. This course provides guidance on the basic steps of this process, summarizes the types of transfers that may occur, and outlines the components of a transfer process. All these general information chapters are part of a family of chapters devoted to providing guidance for the quality of the data-acquisition process. Basic Statistics and Their Practical Applications to USP NF Course #: A031 Duration: 1 day Format: Classroom Learn about the most commonly utilized statistical tests, including t-tests, analysis of variance, correlation, linear regression, and outlier tests. Practical examples and problems drawn from scientific research illustrate statistical concepts and mathematical procedures. Emphasis is placed on appropriate use of statistics and the interpretation of their results. 14 Courses as of July For the latest updates and course information, visit

15 GENERAL CHAPTERS ON COMPENDIAL METHODS Classroom Laboratory Online Developing Compendial HPLC Industry Practices Course #: A017 Duration: multiple options available Format: Classroom or Classroom + Lab Classroom lecture covers High-Performance Liquid Chromatography (HPLC) theory and mechanisms of separations, basic equipment description and practice, system suitability parameters, adjustments allowed to the chromatographic system, and column selection. The optional lab component offers hands-on demonstration of HPLC and trouble-shooting practices. Developing and Validating Dissolution Methods Course #: A018 Duration: 1 day Format: Classroom If you already have a basic understanding of USP s approach to dissolution, build upon this knowledge by learning how to develop and validate dissolution methods for batch release and stability testing. These tests are in vitro performance tests for most dosage forms (e.g., tablets, capsules, suspensions, transdermal patches, and suppositories), and they are important components of the specifications that establish the strength, quality, purity, and bioavailability of a drug product. Dissolution Apparatus 4 Design, Use, Application, and Suitability Course #: A020 Duration: 1 day Format: Classroom Become familiar with the history, design, use, application, and suitability of the USP Dissolution Apparatus 4 (Flow-Through Cell (FTC)), described in USP NF General Chapter <711> Dissolution. Features live presentation of dissolution performance verification testing to demonstrate the steps involved with successfully using the FTC apparatus. Dissolution Basics Course #: A021 Duration: 1 day Format: Classroom Learn the fundamentals and importance of dissolution testing as conducted on either Apparatus 1 or Apparatus 2 per USP NF General Chapter <711> Dissolution. This is an introductory course intended for scientists new to dissolution. (See Dissolution: Theory and Best Practices for this course offered with a day of hands-on laboratory training.) Dissolution Performance Verification Testing (PVT) FREE Course #: B012 Duration: 42 minutes Format: Online, on-demand Get an overview of the role of dissolution PVT and related equipment, as well as answers to common questions. Dissolution Testing for Dietary Supplements Course #: B012 Duration: 2 days Format: Classroom Gain focused, relevant instruction on the fundamentals of dissolution testing as described in USP NF General Chapters <2040> Disintegration and Dissolution of Dietary Supplements and <711> Dissolution. Course covers the theory, practice, and history of dissolution; practical aspects of conducting disintegration and dissolution tests for dietary supplements; and compendial apparatus types used, including Apparatuses 1, 2, 3, and 4. Questions? PharmEd@usp.org. 15

16 GENERAL CHAPTERS ON COMPENDIAL METHODS Classroom Laboratory Online Dissolution: Theory and Best Practices Course #: A022 Duration: 2 days Format: Classroom + Lab Learn the fundamentals and importance of dissolution testing as conducted on either Apparatus 1 or Apparatus 2 per USP NF General Chapter <711> Dissolution and benefit from hands-on laboratory training. In the lab, conduct a dissolution PVT test under the guidance of USP staff. Participants that pass a lecture test and complete the lab element will receive a Certificate of Completion. Essentials of Microbiological Testing Course #: A032 Duration: 1 day Format: Classroom Gain a practical understanding of microbiological testing in the pharmaceutical industry through USP NF General Chapters: <51> Antimicrobial Effectiveness Testing, <61> Microbial Examination of Nonsterile Products: Microbial Enumerations Testing, <1111> Microbial Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use, and <1112> Application of Water Activity Determination to Nonsterile Pharmaceutical Products. HPTLC for Identification of Articles of Botanical Origin Course #: A023 Duration: 2 days Format: Classroom + Lab Receive hands-on training on the current concept, methodology, and parameters for using high performance thin-layer chromatography (HPTLC) to analyze botanical materials in a cgmp-compliant environment. Topics include the identification of raw materials and finished products, the detection of adulteration, the quantitative determination of markers, and investigations of shelf life. Lab segment covers SOPs and their application. In-Vivo In-Vitro Correlation (IVIVC) Course #: A024 Duration: 2 days Format: Classroom Explore the IVIVC link between bioavailability/bioequivalence testing and USP dissolution/drug release testing. Learn how the correlation can help predict in-vivo performance of pharmacopeial dosage forms based on their in-vitro performance an important basis for setting specifications that may be useful in assessing quality, efficacy, and safety of drug products. Course covers oral solid dosage forms (tablets, capsules, and suspensions) as well as transdermal patches and implants. New Proposed Spectroscopy Chapters Course #: B023 Duration: 1 hour Format: Online, on-demand Learn about proposed changes to USP NF general chapters focused on different spectroscopic techniques. The following chapters will be discussed: <851> Spectrophotometry and Light-Scattering; <852> Atomic Absorption; <853> Fluorescence Spectroscopy; <854> Mid-Infrared; <1058> Analytical Instrument Qualification; <1119> Near-Infrared; <1120> Raman Spectroscopy; <1224> Transfer of Analytical Procedures; <1125> Validation of Compendial Procedures; <1226> Verification of Compendial Procedures; and new chapters <1852>, <1853>, and <1854>. Course also briefly addresses new requirements for instrument qualification and procedure validation/verification. 16 Courses as of July For the latest updates and course information, visit

17 GENERAL CHAPTERS ON COMPENDIAL METHODS Orthogonal Methods for Identity: Classical Pharmacognosy Coupled with Instrumental Analysis (Free) see listing on page 9. Pharmaceutical Stability see listing on page 13. Practical Applications of Chapter <467> Residual Solvents Course #: A025 Duration: 1 hour Format: Classroom + Lab Learn how to effectively address implementation issues in the lab related to revisions to USP NF General Chapter <467> that became official July 1, More than just an overview of residual solvents requirements, this course focuses specifically on the analytical procedure contained in <467>, common points of confusion, concerns encountered by the industry, and alternative testing protocols. Spectroscopic General Chapters in the USP NF Course #: A026 Duration: 1 day Format: Classroom Gain comprehensive knowledge of operational guidelines in new spectroscopic USP NF General Chapters <852> Atomic Absorption, <853> Fluorescence Spectroscopy, <854> Mid-Infrared, <857> Ultraviolet-Visible, and <1119> Near-Infrared. Learn how these chapters relate to <1058> Analytical Instrument Qualification, <1224> Transfer of Analytical Procedures, <1225> Validation of Compendial Procedures, and <851> Spectrophotometry and Light-Scattering. Course also addresses future revision of <851>. To help ensure accuracy and relevance, USP courses are created and approved by USP subject matter experts. Understanding USP Requirements for Balances Course #: A027 Duration: ½ day Format: Classroom Become familiar with current text and recent proposals to laboratory weighing and balance properties in USP NF Chapters <41> Balances and <1251> Weighing on an Analytical Balance. Understanding USP Requirements for Weights and Balances Course #: B024 Duration: 1 hour Format: Online, on-demand Discover how following USP NF compendial requirements for weighing and balances can help add to the accuracy of analyses and reliability of analytical data generated. Course covers compendial guidance and requirements for the selection of suitable balances and appropriate weighing procedures needed for performing laboratory analyses. Validation and Verification of Analytical Procedures Course #: A028 Duration: 1 day Format: Classroom Learn about parameters for validating analytical procedures for small molecules based on USP NF General Chapters <1225> Validation of Compendial Procedures and <1226> Verification of Compendial Procedures. Topics include comparing <1225> and <1226> and understanding the differences between <1225> and ICH guidelines. Questions? PharmEd@usp.org. 17

18 Classroom Laboratory Online MEDICATION AND PATIENT SAFETY Compounding TPN Preparation: A 2011 Investigation of a Bacterial Outbreak (FREE) Course #: B025 Duration: 1 hour Format: Online, on-demand Hear about lessons learned from the contamination of compounded total parenteral nutrition that caused an outbreak of Serratia marcescens in adult patients. This public webinar was originally presented September 20, 2011, by the Centers for Disease Control and Prevention and USP. USP <797> Pharmaceutical Compounding Sterile Preparations Course #: A029 Duration: 1 day Format: Classroom Gain in-depth knowledge of key sterile compounding standards in USP NF General Chapter <797> Pharmaceutical Compounding Sterile Preparations. These standards, which became official in 2008, should be understood by compliance officers and followed by practitioners to ensure safe compounding of sterile preparations. History and revisions to <797> are covered. Approved for Continuing Pharmacy Education credit by an Accreditation Council for Pharmacy Educationaccredited provider for pharmacists and pharmacy technicians. USP <795> Pharmaceutical Compounding Nonsterile Preparations Course #: A030 Duration: 1 day Format: Classroom Learn about key components of USP NF General Chapter <795> Pharmaceutical Compounding Nonsterile Preparations. In addition to the latest proposed revisions, the course covers categories of compounding, definitions for terms, and criteria for compounding each drug preparation. Approved for Continuing Pharmacy Education credit by an Accreditation Council for Pharmacy Education-accredited provider for pharmacists and pharmacy technicians. 18 Courses as of July For the latest updates and course information, visit

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