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QUOTED. April 15, 2019. Luann Pendy.

Executive Summary

Medtronic quality VP Luann Pendy worked with the US FDA and the Medical Device Innovation Consortium through its joint Case for Quality devise a so-called "#makeCAPAcool" initiative to recast corrective and preventive action as a continuous learning tool. See what Pendy said about the "monster called CAPA" here.

"I wanted to start this team '#makeCAPAcool' because … industry and FDA have created a monster. We have created a monster called 'CAPA,' and we have to figure out a way to reduce that monster, to get rid of that monster." – Luann Pendy, senior VP of global quality, Medtronic PLC

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