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

Cambridge, MA
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Invest In Your Education. Come to our meeting focusing On "Quality and Compliance Management Issues - Virtual Companies and The Do's and Don'ts of Pre-Approval Inspections: What to Expect When Being Inspected."

Join us for dinner and evening talks led by Dave Chesney and Sean Marcsisin.

Speaker: Dave Chesney

Topic: Quality and Compliance Management Issues – Virtual Companies


Dave's presentation will focus on several key quality and compliance management issues that virtual companies face including:

  • Five common concerns expressed by virtual companies
  • Things every virtual company MUST do to be in GMP compliance
  • Does FDA inspect virtual companies? If so, why?
  • Fundamental GCP concepts for QA leaders from a GMP background

Speaker: Sean Marcsisin

Topic: The Do's and Don'ts of Pre-Approval Inspections: What to Expect When Being Inspected.


Sean will explain the overall FDA pharmaceutical pre-approval inspectional process to include:

  • What triggers an inspection?
  • Items that are evaluated during an inspection
  • Common pre-approval inspectional concerns

Meeting Hosts

Brian Clark, Principal, GMP Operations Consulting
Louis Zackiewicz, Pharmaceutical/ Biotech/ Medical Device Consultant, GxP Quality

Standard Registration

Member Price




See Qualifying Criteria for Member Types.

Day 1

  • 6:00 PM - 7:00 PM - Registration/social with sponsors begins
  • 7:00 PM - 7:30 PM - Dinner
  • 7:30 PM - 9:30 PM - Presentations begin
Agenda is subject to change.

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.

Hyatt Regency Cambridge

575 Memorial Dr
Cambridge, MA ,