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 Regulation of Combination Products (21 CFR Part 4). Each module includes an approximately one-hour video instructional presentation by Kim Trautman, Executive Vice President, Medical Device International Services at NSF International, followed by an assessment on the information covered in the video.
Topics covered during this course include U.S. Quality Systems Regulation 21 CFR 820:
- An overview of FDA and intention of 21 CFR Part 820
- Expectations and up-to-date requirements of 21 CFR Part 820
- A working knowledge in application of the requirements
- An explanation of each section of 21 CFR Part 820 and interpretation with respect to combination products
U.S. Current Good Manufacturing Practice (cGMP) requirements for Combination Products 21 CFR Part 4:
- Overview of 21 CFR part 4 and expectation of the FDA on drug device combination products
- Requirements of single-entity and co-packaged combination products
- Manufacturers of single-entity and co-packaged combination products that contain a device component complying with device Quality System requirements when using the drug cGMP-based streamlined approach
- Other Code of Federal Regulations implications on combination product requirements
By completing/passing this course, you will attain the certificate Medical Device Certificate
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