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Medical Devices

QSIT 1: Beginning the Inspection

About the Course

This is the first course in a series of FDA online training courses on the Quality System Inspection Technique (QSIT). This course provides guidance for inspecting medical device manufacturers against the Quality System Regulation, 21 CFR Part 820. Topics include scope, other considerations, sampling and reporting. Learners will be able to recognize the purpose of QSIT during investigations of medical device manufacturers.