Whether you are testing a starting material (component), an in-process sample, the Active Pharmaceutical Ingredient (API), final product (whether non-sterile or sterile), the environment including controlled and classified areas or the HVAC, you should be aware of the critical role the microorganisms play throughout. You should be aware of the various microbiological related documents, e.g., raw material sampling criteria, in-process, API, final product, environmental and utilities, (many of which have USP microbiological documents as the "bedrock" for building these documents, to determine whether the SOPs, validations as well as government and other regulatory body document requirements are being maintained to assure the control required to permit the final product to enter the marketplace as safe.
The objective of this on-line, interactive two day "Essentials of USP Microbiology" seminar is to explore USP General and General Information Chapters to learn their current and updated status and to confirm that those Chapters being utilized are used correctly. USP documents that will be reviewed include:
- USP<51> Antimicrobial Effectiveness Testing
- USP<60> Microbiological Examination of Nonsterile Products Tests for Burkholderia cepacia Complex
- USP<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
- USP<71> Sterility Tests
- USP<85> Bacterial Endotoxins Test
- USP<1072> Disinfectants and Antiseptics
- USP<1111> Microbiological Examination of Nonsterile Products
- USP<1112> Application of Water Activity Determination to Nonsterile Pharmaceutical Products
- USP<1113> Microbial Characterization, Identification, and Strain Typing
- USP<1116> Microbiological Control and Monitoring of Aseptic Processing Environments
- USP<1227> Validation of Microbial Recovery from Pharmacopeial Articles
Learning Objectives:
- Understanding the various General and General Information USP Chapters that apply to microbiology
- Study the focus of the chapters to include those that primarily involve non-sterile and sterile applications and their interpretation
- Gain an enhanced knowledge of the chapters that involve the microbial environment
- Examining the changes within the various Chapters that have recently occurred and how to interpret them
- Review areas that are often overlooked or often misunderstood
- Study issues that continue to exist between the USP, EP and JP (harmonization)
- Examine the new regulatory attitude that is occurring with non-sterile products
- What now constitutes a "specified" and "objectionable" microorganism
- Explore Form FDA 483s and Warning Letters for microbiological applications
Who Will Benefit:
- Manufacturing
- Product Development
- Project Management
- Quality Assurance
- Quality Control
- Microbiology
- Regulatory Affairs
- Regulatory Compliance
Course Content
Day 01(10:00 AM - 4:00 PM EDT)10.00 AM: Session Start
- Overview of the General and General Information USP Chapters that apply to microbiology
- Focus upon those Chapters that primarily involves both non-sterile and sterile applications
- Explore commonalities and differences between the various Chapter and how they interrelate
- Learn how Chapters that involve the environment impact all other USP Chapters
- Defining the differences between a “Controlled” and “Classified” environment and how they impact the USP Chapters
- Review recently changed USP Chapters to include harmonization and how to interpret them
- Continuing review the balance of the USP Chapters
- Review of areas of USP microbiology that are often overlooked
- Study issues that continue to exist between the USP, EP, and JP
- Examination of the new regulatory attitude that is occurring with non-sterile products
- What now constitutes a “specified” microorganism
- Case Studies and recent Warning Letters
Course Provider
Dr Barry A. Friedman, Ph.D,
Consultant ,
Cambrex Bio SciencesDr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.
Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international.
Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n’ Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.
Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology.
