FDA Medical Device QS Regulation and Inspection Technique (QSIT) (2 hours)

This course provides insight on applying the Quality System Inspection Technique (QSIT). This course was developed by one of the original authors and life-long practitioner of QSIT. Help prepare yourself for an FDA inspection by familiarizing yourself with the same inspection approach used by FDA investigators.

Key learning objectives:

By the end of this module, you should be able to:

• Identify key resources used by the FDA to conduct inspections of medical device manufacturers
• Recognize the types of medical device manufacturer inspections conducted by the FDA
• Recognize key requirements of the Quality System Regulation (21 CFR Part 820) and associated preamble comments
• Identify the seven subsystems of QSIT and how they will be inspected
• Recognize the importance of the role of management with executive responsibility to the success of a quality management system