David L. Chesney, MSJ
Principal and General Manager
DL Chesney Consulting LLC
David Chesney is the principal and general manager for DL Chesney Consulting, providing GMP and GCP compliance consulting and training services to clients worldwide. He has a combination of almost 52 years of experience with this topic. Following a 23-year FDA career, all of it spent in the inspection and enforcement arm of the FDA (the Office of Regulatory Affairs) culminating in the role of District Director in San Francisco, David has spent nearly 29 years helping clients prepare for and manage FDA inspections. For more than 10 years he was also an instructor for the FDA’s new hire training program in food and drug law and evidence development, teaching the fundamentals to recently hired FDA Investigators.
Sessions:
Effective FDA Inspection Handling and 483 Response
How to Ensure Your Drug or Biologics Manufacturing Facility Is Ready to be Evaluated by the FDA Either Remotely or In-Person
The Impact of AI and New Technology
Lessons Learned from COVID-19 & Supply Chain Mayhem
Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections