PDA New England Chapter: FDA Speaker Dinner Meeting

Program Highlights

Title: What to Expect When Being Inspected: An FDA Investigator’s Perspective

Synopsis:

Lieutenant Commander (LCDR) Sean Marcsisin will provide an in-depth look at the FDA’s pharmaceutical inspection process, offering insights from an investigator's perspective. The session will cover various types of inspections, current trends in Current Good Manufacturing Practice (CGMP) inspections, and key resources available to ensure compliance. LCDR Marcsisin will also present real-world CGMP case studies to highlight common challenges. Additionally, attendees will learn about the recent reorganization of FDA’s field operations under the Office of Inspections and Investigations (OII), previously known as the Office of Regulatory Affairs (ORA), and how this change impacts the inspection landscape.

Title: How to Prepare for a Successful FDA Pre-Approval Inspection

Synopsis:

FDA Pre-Approval Inspections (PAIs) are critical in the drug development process, marking a pivotal step toward product approval. Success in these inspections begins with selecting the right Contract Development and Manufacturing Organization (CDMO) and maintaining a collaborative partnership throughout the drug development lifecycle. Leveraging your CDMO's previous experiences and expertise can help identify and avoid potential compliance risks. This session will highlight best practices employed by PCI Services to effectively prepare for and navigate FDA PAIs, ensuring readiness and minimizing the risk of approval delays.