QS Regulation 5: Identification and Traceability; Production and Process Controls

<p>The fifth in a series of Quality System (QS) Regulation courses, this course focuses on Identification and Traceability (21 CFR Part 820, Subpart F) and Production and Process Controls (21 CFR Part 820 Subpart G). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. Topics in this course include: Identify and Trace, Production Processes, Controlling Changes, Other Controls, Software Validation, Equipment Calibration, and Process Validation. After completing this course, leaners will be able to recognize a manufacturer’s responsibilities relative to the Identification and Traceability requirements and Production and Process Controls requirements of the QS Regulation.</p>

After this course learners will be able to recognize a manufacturer's responsibilities relative to the identification and traceability requirements and production and process controls requirements of the qs regulation.