Combination Products Summit: Streamlining 21 CFR Part 4 Compliance
7:00 a.m. – 8:00 a.m. |
Registration and Continental Breakfast |
8:00 a.m. – 8:30 a.m. |
Welcome |
8:30 a.m. – 9:15 a.m. |
FDA’s Expectations for Combination Products Manufacturers — Review of 21 CFR Part 4 Requirements
John (Barr) Weiner, Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA |
9:15 a.m. – 10:30 a.m. |
FDA and Industry Interactions; Cultivating a Relationship of Transparency
Christy Skinner, Quality Assurance, W.L. Gore and Associates
|
10:30 a.m. – 10:45 a.m. |
Break |
10:45 a.m. – 12:15 p.m. |
FDA and Industry — Expert Panel Discussion — Things That Keep You Up at Night
Moderator:
Panelists: |
12:15 p.m. – 1:15 p.m. |
Lunch |
1:15 p.m. – 4:30 p.m. |
How and When to Implement 21 CFR 820.30 Design Controls
Case Study: Understanding PMOA Before Your Product is DOA
Olivia Wong, Director, NSF Health Sciences, Medical Device Consulting
|
4:30 p.m. – 6:30 p.m. |
Networking Social |
Who will benefit?
- Engineering Managers
- Quality Engineers
- Analytical Chemists
- Compliance Managers – Training and Internal Audit oversight
- Purchasing and Supply Chain Managers
- Procurement Agents involved in outsourcing production or processes
- R&D staff – Engineering, and Analytical Lab personnel
- Medical staff evaluating risk, safety, or effectiveness
- Regulatory Affairs Managers
- General/Corporate Counsel
- Directors and Managers responsible for delivery and execution to 21 CFR Part 4 requirements
- Those involved with the day-to-day activities of combination product design, development, validation and production within quality, regulatory, laboratories, engineering, R&D and operations organizations