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Course Instructor

Barry Friedman Ph.D.

Senior Consultant in Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing


Barry A. Friedman, Ph.D. is a Senior Consultant in the biotechnology, regulatory compliance, microbiology, and aseptic processing arenas. 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 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 compliance interactions.

Dr. Friedman has over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices, including 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 is a member of ASM and PDA. He served as a Captain in the Medical Service Corps, U.S. Army, and is the past President and 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.

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