PDA New England Dinner: "Quality & Compliance Management Issues" and "What To Expect When Being Inspected"

David Chesney is an independent consultant with 47 years’ experience (FDA and private sector). His FDA experience was in the field organization, beginning in the “Boston” District, ending as the District Director in San Francisco, moving on to become VP and Practice Lead for PAREXEL Consulting. In 2016 he formed DL Chesney Consulting, LLC. Dave has an MS in Jurisprudence in Pharma and Medical Device Law (Seton Hall University Law School), a BS in Biology (CSU, Northridge), and postgraduate work in biology at CSU, San Diego. Dave teaches for PDA’s Training and Research Institute, the Food and Drug Law Institute, and serves as adjunct faculty for the Maine Regulatory Training and Ethics Center, University of Maine Law School.

Sean Marcsisin has been with the Food and Drug Administration (FDA) for four years with the Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs. Sean serves as an investigator in Pharmaceutical Quality and as a subject matter expert on current good manufacturing practices (cGMP) for pharmaceuticals. Sean’s roles and responsibilities include planning, conducting, and leading cGMP and Pre-Approval inspections of pharmaceutical and biopharmaceutical firms, both foreign and domestic. Prior to joining the FDA, Sean served on active duty with the U.S. Army as a scientist, where he contributed to the pharmaceutical development of therapies for neglected tropical diseases.