PDA New England Chapter: FDA Speaker Dinner Meeting

Woburn, MA
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The PDA New England Chapter cordially invites you to an FDA Speaker Dinner Meeting.

Event Details

  • Topic: History and Overview of Drug CGMPs and Current Insights: An Investigator's Perspective
  • Presenter: Sean Marcsisin, Ph.D., RAC, ASQ-CPGP , FDA Office of Pharmaceutical Quality Operations

Lieutenant Commander Sean Marcsisin has been with the Food and Drug Administration for seven years, all of which have been with the Office of Pharmaceutical Quality Operations conducting domestic and foreign pharmaceutical inspections. Sean has experience with all types of human and animal pharmaceutical inspections that include: 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 Sean 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.

More information coming soon.

Day 1

  • 5:30 - 6:30| Sponsor/Networking Hour
  • 6:30 - 7:00| Dinner
  • 7:00 - 7:15 | Opening Remarks and Introductions
  • 7:15 - 9:00 | Speaker Presentations with Q & A
Agenda is subject to change.

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