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

11 Mar 2020
Cambridge, MA

Become a Sponsor and/or Exhibitor

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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

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."

Agenda

Discover What's Happening Each Day
Day 1 12 Mar
Thursday, 12 March
  • 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

Location and Travel

Venue Details and Accommodations

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

Registration

Pricing Options

Standard Registration

Member Price

$135.00

Non-Member

$135.00

See Qualifying Criteria for Member Types.

Sponsor information will be available soon

We're currently finalizing our list of sponsors and will share the details shortly.

Become a Sponsor and/or Exhibitor

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Become a Sponsor

Elevate your brand and maximize your exposure by becoming a sponsor at the PDA New England Dinner: 'Quality & Compliance Management Issues' and 'What To Expect When Being Inspected'! Connect with industry leaders, showcase your products and services, and establish your company as a key player in the field.

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Become an Exhibitor

Boost your brand and visibility by becoming an exhibitor at the PDA New England Dinner: 'Quality & Compliance Management Issues' and 'What To Expect When Being Inspected'! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.

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Contact

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Tel: +1 (301) 656-5900

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