U.S. Medical Device Quality System & Combination Products Regulations – Practical Instruction

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:

• Comprehensive instruction on the U.S. Quality Systems Regulation 21 CFR Part 820
• Instruction on how to apply the requirements of each section of 21 CFR Part 820
• An Overview of the U.S. current Good Manufacturing Practice (cGMP) requirements for combination products

• Overview of 21 CFR Part 4, providing insight on FDA’s expectations for drug/device Combination Products
• U.S. 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

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).