FDA Inspections of Medical Device Manufacturers


1.5 hours

Course Overview

In preparation for an FDA inspection, it is important to familiarize yourself with the tools used by FDA investigators to conduct the inspection and to assess inspection outcomes to determine if further FDA action is necessary. The Quality System Inspection Technique, QSIT, is the primary tool used to conduct FDA inspections of medical device manufacturers. QSIT is publicly available and will be the primary focus of this module.



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