PDA New England Dinner: 'Quality & Compliance Management Issues' and 'What To Expect When Being Inspected'
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Individual Registration
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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
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
Contact
Chapter Inquiries
Membership Services
Standard Pricing
Standard Member Price
$135.00Non-Member
$135.00
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
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 DrCambridge, MA ,