QSIT 5 -- The Production and Process Controls Subsystem

This is the fifth 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. Topics in this course include: Selection, Control and Monitoring, Operating Limits, Validation, Software, and Personnel. After completing this course, learners will be able to recognize the inspectional objectives related to the Production and Process Controls subsystem.

After this course learners will be able to recognize the six inspectional objectives of the production and process controls subsystem and techniques for accomplishing those objectives.