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2021 ISPE Annual Meeting & Expo

Concurrent Session: Lessons Learned on Virtual Inspections and What to Take Forward Post-Pandemic


Nov 2, 2021 2:00pm ‐ Nov 2, 2021 3:30pm


Description

Concurrent Session: Lessons Learned on Virtual Inspections and What to Take Forward Post-Pandemic|This session will explore how both industry and regulatory authorities have adapted to manage our governance responsibilities during the COVID-19 pandemic when travel was restricted, and resources of many types were scarce.  We will discuss the Lessons we have Learned – what worked, what didn’t work so well, and what we feel is valuable to take forward as we move into the “new normal” with more remote work.  Speakers will represent a global perspective including the cross-industry collaboration on the IFPMA paper on Virtual Inspections, results from the EFPIA Survey on Inspection Practices, as well as insights from both MHRA and WHO.

Session Leader(s):

Speaker(s):

  • Sarah Barkow, PhD, Director GxP External Engagement, BMS
  • Stephan Rönninger, Dr.-Ing., Director, Quality External Affairs, Amgen (Europe) GmbH
  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA
  • Joey Gouws, PhD, Team Lead, Inspection Services, Prequalification Team, World Health Organization
  • Ian Jackson, Unit Manager, Inspection Risk, Control and Governance, MHRA
  • Jennifer Maguire, PhD, Deputy Director, Office of Quality Surveillance, CDER/FDA
  • Ewan Norton, Lead Senior GMDP Inspector, MHRA

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