Overview

On July 10, FDA announced it would resume prioritized domestic inspections based on a rating system of the COVID-19 virus trajectory in a given state and applicable local rules and regulations. The agency will also continue to utilize alternative means, such as record review, as well as relying on self-policing requirements such as cGMPs. This webinar will address tools the agency is using to ensure industry compliance during the COVID-19 pandemic and legal authority and limitations underlying these tools. The panelists will also discuss logistical and legal challenges facing industry in the context of inspections, and ways for industry to respond to these challenges.

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Speakers

Kalah Auchincloss, SVP, Regulatory Compliance & Deputy General Counsel, Greenleaf Health, Inc.
Jack C. Garvey, Chief Executive Officer, Compliance Architects LLC
Moderated by Neeraj Pai, Partner, Sidley Austin LLP

 

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