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Medical Devices

QSIT 5: The Production and Process Controls Subsystem

About the Course

This is the fifth and final course in a series of FDA online training courses on the Quality System Inspection Technique (QSIT). Topics include guidance for inspecting medical device manufacturers against the Quality System Regulation, 21 CFR Part 820. Learners will be able to recognize the inspectional objectives related to the production and process controls subsystem. Prerequisites include: Completion of Level 1 new hire investigator certification, review of IOM, CP 7382.845 “Inspection of Medical Device Manufacturers,” 21 CFR Part 820 – Quality System Regulation, and the Guide to Inspection of Quality Systems, and the four other courses in this series.