QSIT 4 -- The Corrective and Preventive Actions Subsystem

This is the fourth in a series of courses designed to instruct on the Quality System Inspection Technique (QSIT). The series provides guidance for inspecting medical device manufacturers against the Quality System Regulation, 21 CFR Part 820. This course will cover the inspectional objectives related to the Corrective & Preventive Actions subsystem. Before taking this course, employees must complete Level I New Hire Investigator Certification. They must review the IOM (as it pertains to the inspection of medical device manufacturers), CP 7382.845 “Inspection of Medical Device Manufacturers,” 21 CFR Part 820 – Quality System Regulation, and the Guide to Inspection of Quality Systems. Employees must also have completed QSIT 1 — Beginning the Inspection, QSIT 2 — The Management Controls Subsystem, and QSIT 3 — The Design Controls Subsystem.