QSIT 2 -- The Management Controls Subsystem

This is the second 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 Management Controls subsystem. Employees should complete QSIT 1: Beginning the Inspection prior to taking this course. They must also complete the Level I New Hire Investigator Certification. Employees should 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.