Inspections are a critical component of FDA’s enforcement authorities to ensure compliance with FDA rules and regulations and COVID has caused the inspections process to only become more complicated. Properly preparing the facility, documentation, and staff in advance of an inspection is vital for success. In this webinar, experts will discuss best practices for assessing vulnerabilities and strengths, preparing subject matter experts, and planning for documentation. They will also discuss FDA’s newly released draft guidance, Conducting Remote Regulatory Assessments: Questions and Answers, the specific challenges of remote workforces, and the potential of remote interactive evaluations.

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Cathy L. Burgess, Partner, Alston & Bird LLP and Member, FDLI Board of Directors
David L. Chesney, Principal and GM, DL Chesney Consulting, LLC 
Christopher Fanelli, Partner, Sidley Austin LLP
Moderated by Bob A. Rhoades, Managing Partner, Validant 
Additional speakers pending

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