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