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QSIT At 15: Two Co-Creators Of FDA’s Aging Audit Technique Look Back – And Mull Over Today’s Agency Approach

This article was originally published in The Silver Sheet

Executive Summary

Now that FDA’s Quality System Inspection Technique is 15 years old, is it time for a facelift? Two ex-FDA officials who were part of the FDA team that developed QSIT say the inspectional approach is still relevant, but perhaps for different reasons than were envisioned in 1999. Former QSIT team leader Tim Wells says the technique can serve as “a roadmap to quality system compliance” for medical device manufacturers, yet fellow team member and ex-investigator Denise Dion is concerned about changes the agency has made over the years to how such audits are conducted. In a Q&A with “The Silver Sheet,” the duo also talk about why QSIT was devised in the first place, a struggle by the Office of Regulatory Affairs to keep facility walk-throughs in the technique and whether they believe QSIT will ever be revised, among other topics.

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