2026 FDA Inspection Training 21min

The FDA released a new inspection guidance for the QMSR on February 2. The new inspections methods are risk-based and very different from the previous QSIT inspection manual. This video reviews some of the basic elements of that guidance. The new inspection guidance describes process audits that are risk-based with six major inspection areas and 23 elements that are sampled. You can download the inspection guidance and obtain more training on the preparation for FDA medical device inspections at: https://medicaldeviceacademy.com/fda-...