
PDA New England Dinner: 'Quality & Compliance Management Issues' and 'What To Expect When Being Inspected'
Become a Sponsor and/or Exhibitor
Registration Options
Individual Registration
Group Registration
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
- 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 DrCambridge, MA
Registration
Pricing Options
Standard Registration
Member Price
$135.00Non-Member
$135.00
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
Amplify Your Presence and Reach Your Customers!
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.
Request InformationBecome 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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