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‘War Room’ Death Knell? Edwards Lifesciences Expert Predicts Inspectional Front, Back Rooms Will Be Pandemic Victim

 
• By Shawn M. Schmitt

Medtech quality expert Rob Becker says the COVID-19 pandemic has likely changed the structure of audits and inspections forever, possibly ending the use of on-site “front rooms” where inspectors would work and “back rooms” where company employees would fulfill requests for documents and other items.

Small black bell hanging.

When inspected by the US Food and Drug Administration or audited by a notified body, many device makers have set up separate “war rooms” for inspectors to work in and for subject matter experts and others to fulfill in-person regulator requests.

But the COVID-19 pandemic has likely changed that forever, says Rob Becker, senior quality director for Edwards Lifesciences Corp.

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