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

DAVID L. CHESNEY, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients world wide. He served for over 20 years as Vice President, Strategic Compliance Services for PAREXEL Consulting. Prior to joining PAREXEL Consulting, he served 23 years with the FDA as an Investigator, Supervisory Investigator, Director of Investigations and ultimately as District Director in San Francisco, managing all FDA operations in Northern California, Nevada and Hawaii.

Mr. Chesney holds an MS in Jurisprudence, concentrating in Pharmaceutical and Medical Device Law from Seton Hall University School of Law, a Bachelor's degree in Biology from California State University, Northridge, plus three years of graduate study in Biology at CSU Northridge and CSU San Diego. Mr. Chesney is a member of PDA, where he serves on the faculty of the Training and Research Institute. He is also active in the Food and Drug Law Institute and RAPS.

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.