John R. Godshalk, MSE, MBA joined Biologics Consulting as a Senior Consultant in December 2005. John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) for 3½ years. Prior to joining FDA he worked as a management consultant after obtaining his MBA.
During his tenure at DMPQ, John gained experience with products that include drugs, drug/device combination products, viral and bacterial vaccines, recombinant therapeutic and fractionation products, in vitro diagnostic test kits, and 510K medical devices. His inspection experience includes leading inspections of active pharmaceutical ingredient manufacturers, aseptic filling and finishing facilities, and contract manufacturers. He has performed numerous pre-approval and pre-licensing inspections for biological and biotechnology products. In addition, he has evaluated industry responses both for technical and regulatory merit during FDA regulatory compliance actions, and has assessed these responses and offered alternative solutions to resolve technical issues and regulatory concerns. John gained extensive experience in evaluating pharmaceutical product facility design, assessment of validation approaches, and evaluation/development of regulatory strategy through both review work and representing CBER at numerous Type C meetings (i.e., facility, validation, and regulatory strategy related) with industry. John has provided advice to industry on regulatory strategies, best practices, and development of streamlined and leveraged validation approaches that meet FDA licensing requirements.
John has developed and given training programs for the FDA and regulated industry on pharmaceutical water, processing and instrumentation, lyophilization, cleaning methods and validation, and facilities for gene therapy. He contributed to formulation of FDA policy as a member of the committee writing the Guidance Document for the Facilities and Controls for Cellular and Gene Therapy Product Manufacturing Operations. John has served as chair in the review of the Chemistry Manufacturing and Controls (CMC) sections of Biologics License Applications and Supplements for both novel and licensed biological products at CBER. He has trained CBER staff on the scientific and regulatory review and evaluation of these applications and supplements. Prior to joining FDA, John used his business experience and MBA as a consultant in the areas of business planning, marketing, information technology and strategic planning, financial modeling and analysis, budgeting, business process engineering, project management, and management consulting.
At Biologics Consulting John utilizes his depth of experience in cGMP, regulatory affairs and management consulting to assist clients in the following areas:
M.B.A., Finance and Marketing, Univ. of Maryland, College Park, MD, and Merrick School, University of Baltimore, Baltimore, MD. (1997)
M.S.E., Chemical and Biochemical Engineering, Johns Hopkins University, Baltimore, MD (1984)
B.S., Chemical Engineering, North Carolina State University, Raleigh, NC (1982)