This course includes six modules. The first five modules cover the U.S. Quality Systems Regulation (21 CFR 820) and the sixth module covers the Combination Products Regulation (21 CFR Part 4). Each module includes a one-hour (approximate) video instructional presentation by former FDA official Kim Trautman, followed by a comprehensive assessment.
Topics covered during this course include:
This course is vital for any medical device regulatory affairs or quality assurance professional, as well as R&D engineers and scientists.
When Successfully Completing NSF’s U.S. Quality Systems and Combination Products Training, you will attain a Certificate of Successful Completion – 21 CFR Part 820 (7 hours).