David J. Bergeson

David J. Bergeson

David J. Bergeson

Principal Consultant

David draws on 51 years of regulatory affairs expertise to assist FDA regulated companies in achieving compliance with the Agency’s Good Manufacturing Practice (GMP) Regulation, Quality System Regulation (QSR) and Electronic Records; Electronic Signature (ER/ES) Regulation requirements.

Work Experience

David utilizes his experience to assist clients in identifying and remediating GMP and QSR issues, both prior to their discovery by the FDA and subsequent to FDA regulatory actions, including remediation of Consent Decrees. David has expertise in; a) preparing the software sections of Medical Device marketing applications; b) conducting audits to prepare a client for regulatory pre approval inspections; and c) delivering training in computer and software system validation.

Prior to joining Parexel, David was an Investigator with the US Food and Drug Administration. His last position with the Agency was that of a National Expert Investigator specializing in the regulatory compliance of computer and software systems. His experience with the Agency covers nearly all regulated commodities, including medical devices (e.g., implantable, software controlled), pharmaceuticals (sterile dosage forms, solid dosage forms, creams, ointments, veterinary drugs, computer systems validation), biologics, etc. While with the Agency he trained FDA personnel and was a primary author of the guidance documents, General Principles of Software Validation and Glossary of Computer System and Software Development Terminology.

Education

David holds a B.S. in Computer Science from the Wichita State University. He is a speaker at industry forums and has authored an article for an industry periodical.David holds a B.S. in Computer Science from the Wichita State University. He is a speaker at industry forums and has authored an article for an industry periodical.

We are always available for a conversation.

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