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Medical Devices

QSIT 4: The Corrective and Preventive Actions Subsystem

About the Course

This is the fourth course in a series of FDA online training courses on the Quality System Inspection Technique (QSIT). Topics include procedures, problems, received data, failure investigations, actions, documentation, communications, and guidance for inspecting medical device manufacturers against the Quality System Regulation, 21 CFR Part 820. Learners will be able to identify the 10 inspectional objectives associated with the CAPA subsystem and recognize methods to accomplish those objectives.