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.
Join us for an influential and dynamic FDA Dinner Meeting and Discussion hosted by the New England Chapter. Our agenda features two esteemed speakers, Lieutenant Commander Sean Marcsisin and Tom McGrath. These handpicked pioneers are prepared to delve into "What to Expect When Being Inspected: An FDA Investigator's Perspective" and "How to Prepare for a Successful FDA Pre-Approval Inspection." This is a dinner discussion you cannot afford to miss.
This exclusive event will take place at the Courtyard Boston Marlborough.
We look forward to seeing you there!
Event Location
75 Felton St., Marlborough, MA 01752 Get DirectionsContact
Chapter Inquiries
Membership Services
| Registration Type | Early Bird | Late Registration (after 25 October, 2024) |
|---|---|---|
| PDA Members | $85.00 | $135.00 |
| PDA Non-Members | $115.00 | $135.00 |
| PDA Student, Retired and Unemployed Members | $20.00 | $135.00 |
Day 1
5:30pm - 6:45pm | Sponsors/Networking Hour
6:45pm - 7:45pm | Dinner
7:45pm - 8:45pm | Speaker Presentation and Q&A
Featured Presenters
-
Sean Marcsisin
Lieutenant Commander, US Public Health Service Senior Consumer Safety Officer, FDA
Read Bio
Sean Marcsisin
FDA
Lieutenant Commander Sean Marcsisin has been with the Food and Drug Administration for nine years, all of which have been conducting domestic and foreign pharmaceutical inspections. Sean has experience with all types of human and animal pharmaceutical inspections including: pre/post-approval, sterile, non-sterile, biologic, active pharmaceutical ingredient (API), pharmacy compounding, and positron emission tomography (PET) drug inspections. Prior to joining the FDA, Lieutenant Commander Marcsisin 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.
-
Thomas McGrath
VP Global Quality Development & Manufacturing Services, PCI
Read Bio
Thomas McGrath
PCI
Tom has over 25 years of in drug development, quality, and regulatory roles, with the last decade+ focused on aseptically processed pharmaceuticals and medical devices. Prior to assuming his current role in 2014, he was Sr. Director of Quality for Aseptic Services at AMRI–Burlington(now Curia), where he led successful remediation efforts. Before that he held development and quality positions of increasing responsibility at AMAG Pharmaceuticals, CombinatoRx and Praecis Pharmaceuticals. Tom received his B.A. degree in Chemistry from The College of the Holy Cross.
Thank You to Our Sponsors
Platinum
Gold
Silver
Bronze
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.