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David L. Chesney served 23 years in the FDA as an Investigator, Supervisory Investigator, Director of Investigations and District Director.  His FDA career spanned four different FDA Districts (New England, Seattle, Philadelphia and San Francisco).  He also served for over a decade as an instructor for the agency’s Law and Evidence Development training program for newly hired FDA Investigators and Laboratory Analysts.

He holds an MS in Jurisprudence with concentration in pharmaceutical and medical device law from Seton Hall University School of Law, and a BA in Biology from California State University, Northridge.  He completed three years of graduate study in Biology at California State University, divided between the Northridge and San Diego campuses.

After leaving FDA, he served over 20 years as Vice President and practice lead for the GxP consulting arm of a major CRO, helping clients world wide to achieve sustainable GxP compliance and to remediate regulatory concerns across all GxP disciplines.  He founded his private consulting practice in 2016, based in Cumberland Foreside, Maine (Portland area).

David is an active member of the Parenteral Drug Association (PDA), the Food and Drug Law Institute (FDLI), and the Regulatory Affairs Professionals Society (RAPS).  An experienced speaker and trainer, he serves as an instructor for PDA’s Training and Research Institute and FDLI’s "Introduction to Drug Law" program.  He has also served in the past as an external instructor for the Compliance Certification program at the Maine Ethics and Regulatory Training Center (MeRTEC), University of Maine Law School.

David has served as a litigation advisor to law firms, and as an expert witness in private litigation and arbitration cases.  He has been deposed several times and provided live testimony in court cases and arbitration hearings.

He firmly believes that pharmaceutical companies who put patients first and focus on what is best for them establish the optimum cultural orientation for development of sound quality and compliance management practices.

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