U.S. Quality Systems & Combination Products
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 an approximately one-hour video instructional presentation by Kimberly Trautman, Executive Vice President, Medical Device International Services at NSF International, followed by an assessment on the information covered in the video.
Kimberly Trautman has over 30 years of experience in medical device quality systems and international regulatory affairs. She led international initiatives for the U.S. FDA including conceiving, developing and launching the international Medical Device
Single Audit Program. She wrote the current U.S. FDA Medical Device Quality System (QS) regulation, 21 CFR 820, and led the implementation associated with the QS regulation. She also led the harmonization efforts for ISO 13485 since its inception in 1994, serving as international participant to ISO/TC 210 and the U.S. Technical Advisory Group co-chair for ISO/TC 210.
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
For more information Visit University Website.
Certification / Credits
By completing/passing this course, you will attain the certificate Medical Device Certificate
About NSF International
NSF Health Sciences partners with life science companies, big and small, to provide highly customized end-to-end services throughout the product lifecycle. From early development to commercial manufacture and distribution, our expert services will assist you to: Ensure regulatory compliance Implement...
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