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The Ins and Outs of FDA Inspections

Preparing for and Responding to Inspections, Minimizing Legal Risk, and Understanding Changes to FDA Policy and Practice

Thursday, February 25, 2021
Arnold & Porter Webinar

When the COVID-19 pandemic began, the Food and Drug Administration suspended much of its inspection program. With the increasing availability of vaccines, we expect FDA will resume physical inspections in the coming months and likely move aggressively to address backlogs in both product application and overall compliance assessment applications. The new administration has signaled its intent to rigorously oversee the quality of FDA-regulated products, and an increase in both inspection and enforcement is likely.

Join us for this webinar addressing many of the elements that lawyers and regulatory professionals should know about FDA inspections and related enforcement. Whether your company is new to FDA oversight or has been dealing with FDA inspections for years, this webinar will provide practical information your firm needs to know in order to be ready.

Topics

  • Types of FDA inspections (e.g., manufacturing, bioresearch, etc.) and how they are classified.
  • How to prepare for an inspection and how to respond to inspection findings and compliance actions.
  • Links between inspections and various liabilities and government contracts.
  • Approaches FDA may take as it reinstitutes inspections, such as the increased use of document requests, partial reliance on foreign inspectional findings and possible use of virtual inspections.
  • Best practices to help companies make their best case to the agency both during and after an inspection.

Meet the Speakers

Howard Sklamberg
Partner
Arnold & Porter
Mahnu V. Davar
Partner
Arnold & Porter
Daniel A. Kracov
Partner
Arnold & Porter
Raqiyyah Pippins
Partner
Arnold & Porter
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