Expert Profile

Barry A Friedman
Consultant in Biotechnology, Friedman Consulting LLC

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.

Trainings by Expert

Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)
Category: Biotechnology , All FDA Regulated Industry , Quality and Safety , Laboratory , Contamination Control , Quality & Safety , Biotech Regulations , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC

Quality Metrics and the Issues with the FDA’s Revision Draft Guidance Quality Metrics Data
Category: All FDA Regulated Industry , FDA Audit and Inspection , Documentation and IT , Quality & Safety , Risk Management & Controls , All FDA Regulated Functions , Audit & Inspection-Role , All FDA Reg. based Audit , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC