The objective of this two day "Essentials of USP Microbiology" seminar is to explore USP General and General Information Chapters to learn which are available and to confirm that those that you are using are being used correctly. USP documents that will be reviewed include USP <51>, <61>, <62>, <71>, <1072>, <1111>, <1112>, <1113>, <1116> and others. Various team exercises will be conducted to allow the participants to use these USP documents to solve "real life" problems. Plan to bring a cross-functional group of your personnel to attend this invaluable two day seminar.
- The various General and General Information USP Chapters that apply to microbiology
- The focus of the chapters to include those that primarily involve non-sterile and sterile applications
- Chapters that involve the environment
- Examining the changes within the various Chapters that have recently occurred and how to interpret them
- Review areas that are often overlooked
- Study issues that continue to exist between the USP, EP and JP
- 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:
- Product Development
- Project Management
- Quality Assurance
- Quality Control
- Regulatory Affairs
- Regulatory Compliance
Meet Your Instructor
Barry A. Friedman, Ph.D
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. 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.
Note: Use coupon code < NB5SQH8N > and get 10% off on registration
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When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.