In preparation for an FDA inspection, it is important to familiarize yourself with the tools used by FDA investigators to conduct the inspection and to assess inspection outcomes to determine if further FDA action is necessary. The Quality System Inspection Technique, QSIT, is the primary tool used to conduct FDA inspections of medical device manufacturers. QSIT is publicly available and will be the primary focus of this module.
By the end of this module, you should be able to:
- Identify key resources used by 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 Q-SIT; 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
By completing/passing this course, you will attain the certificate Medical Device Certificate
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