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Inside ‘Case For Quality’ Forum: FDA Ponders ‘Critical-To-Quality’ Inspectional Approach

This article was originally published in The Silver Sheet

Executive Summary

FDA is considering focusing inspections on ‘critical-to-quality’ practices as part of its ‘Case for Quality’ initiative. A pilot will be launched this year to identify practices related to particular device types or quality system requirements, an agency official says. Critical-to-quality issues were just one topic discussed at an April 30 FDA national forum on the Case for Quality, which was off-limits to media. “The Silver Sheet” got the inside skinny from three industry experts who attended the meeting.


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