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

Mar 11 - Mar 11, 2020
Cambridge, MA

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Overview

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

Abstract

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.

Abstract

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

Agenda

    • 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

Highlighted Speakers

David L. Chesney
David L. Chesney
DL Chesney Consulting, LLC
Sean Marcsisin
Sean Marcsisin
FDA

Travel

Hyatt Regency Cambridge

575 Memorial Dr
Cambridge, MA

Directions

Registration Fees

Early Registration Price
Registration Type Price By March 5th
Member $95.00
Non-Member $115.00
Student $20.00
Retired $20.00
Unemployed $20.00



































Regular Registration Price
Late Registration Type* Price March 6th  - 9th
Member $135.00
Non-Member $135.00

Attendee registrations will close by 5:00 pm on Monday, March 9th.

Walk-ins are welcome to pay at the door with credit card, based on space availability.

*For event questions or inquiries on late registration availability, please contact [email protected].





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