Thursday, February 15, 2018
12:00 Noon – 1:30 pm EST
Instructor: Barry A. Friedman, Ph.D.
USP/FDA Microbiological Non-Compliance Issues represent often observed problems that occur with both non-sterile and sterile products in controlled and classified environments as well as within the microbiological laboratory. Various regulators will cite firms for these non-compliance issues under a variety of different sections of the Code of Federal Register (CFR) to include 21 CFR 211.113(a) and (b), 211.84(d)(6), 211.165(b), and 211.192. Non-compliance issues are also cited as per United States Pharmacopeia to include USP<51>, <61>, <62>, <71>, <1072>, <1111>, and <1116>. Also, various Guidances for Industry are also included and often used within citations. One of the most notable is the September 2004 FDA Guidance for Industry on Aseptic Processing.
Some of the most frequent non-compliance issues include those within the laboratory, the classified environment, failure to meet USP, non-conformances of personnel, and cleaning and disinfection practices. In today’s environment, often they include “Data Integrity”. This live, interactive Executive Conference webinar will also review various investigations – using various FDA Warning Letters to explore issues with bacteria and fungi. A chronology will be included that reviews microbiological non-compliance.
The Objective of this live, interactive Executive Conference Corp training webinar is to explore the “Best Practices for Managing Microbial Non-Compliances” and examine solutions to common microbiological problems. Please plan to bring a team to this Webinar to explore how these issues may assist you in your facilities.
By attending you will learn:
- An Overview of “Microbiological Non-Conformance Issues”
- Various Code of Federal Register regulations, USP and FDA Guidance for Industry documents used by Regulators in Citations.
- Learn about the Legal Framework behind these Documents.
- Learn about Laboratory, the Classified Environment, Non-conformances of Personnel, and cleaning and Disinfection Practices.
- Explore various Microbiological “Data Integrity” issues
- Participate in an Overview of a “Troubleshooting” Exercise.
- Experience what Companies have encountered with Warning Letters.
$385 for one person
$700 2-5 people
$999 6-10 people
About the Instructor:
Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing arena. From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD. In that capacity as the Director, 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 compliance interactions.
Dr. Friedman has over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness assistance, quality control, sterility assurance, microbiological/analytical validations and fermentation technology. In addition to the associations listed above, other associations have included Chesapeake Biological Laboratories, W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.
Dr. Friedman is a frequent seminar and webinar speaker and specializes in the areas of regulatory compliance, internal auditing, aseptic processing for sterile drug products, USP and Warning Letter “dissection”, multi-departmental interactions, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi, TungstenShield, Compliance OnLine, IPA (Canada) and Pharmig (UK). He maintains an active Blog (www.barryafriedmanphdllc.com) that contains over 200 Blogs that address various Warning Letter and FDA 483 issues. The Blog also contains over 1,500 “Search” terms to enable one to locate a particular regulatory action. He is a member of ASM, PDA and RAPs. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President and current Treasurer of the Capital Area Chapter, PDA. He recently received the James Agalloco award from PDA which is awarded to a PDA faculty member who exemplifies outstanding performance in education.