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Edward A. Fitzgerald, Ph.D., Associate Consultant, Biologics,
started his regulatory career with the Bureau of Biologics, predecessor of the
current Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration in the early 1970's. Dr. Fitzgerald is considered an expert in
CGMPs, including biological standardization, sterile/aseptic processing,
manufacturing of viral and bacterial vaccines, and microbiological quality control.
He develops validation protocols for such process parameters including environmental
monitoring, aseptic processing and bioassays; and reviews and develops SOPs. He
also conducts PAI or annual audits for his clients. He assists in the preparation
of Biologics License Applications, liaises with FDA for IND/BLA meetings, and
provides guidance in responding to FDA Warning Letters and Form 483 items. Dr.
Fitzgerald has been actively involved in regulatory research in the areas of
sterility, purity, potency and safety testing of products regulated by the FDA.
Dr. Fitzgerald has participated in several WHO Collaborative Studies to develop
International Standards for Rabies Vaccines and Rabies Immune Globulin. He has
participated as an invited expert in WHO consultations on rabies vaccines for
human use. During his tenure with FDA, he held many different positions, including
CBER inspector for over twenty years and was appointed Deputy Director, acting
Director and finally Director of the Division of Product Quality Control. He and
his staff were responsible for lot-by-lot release of regulated biological products,
review and quality control testing of these products, and conducted applied research
aimed at improving quality control testing. Dr. Fitzgerald is a member of the
International Association for Biologicals, the American Society for Microbiology,
and the PDA.
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