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Compliance Corner: 5 Tips For Successful FDA Inspections, From SOPs To Roleplaying

 
• By Shawn M. Schmitt

Four industry experts – including a Medtronic quality VP and two former FDA investigators – offer advice on how device manufacturers can better ensure smooth sailing during an FDA audit.

Compliance

From offering an FDA investigator a cup of coffee to discovering the best communicators to explain complex issues, four industry insiders share tips on how device manufacturers can better ensure smooth sailing during a facility inspection.

Comments from the experts, which came during a panel discussion at the 11th annual FDA Inspections Summit in Bethesda, Md., were edited by Medtech Insight for clarity.

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