Combination Products Summit: Streamlining 21 CFR Part 4 Compliance
8:00 a.m. – 8:30 a.m. |
Continental Breakfast |
8:30 a.m. – 10:00 a.m. |
Understanding 21 CFR 211 Laboratory Controls
Dr. Dvorah Feder, Director, Analytical Chemistry Research & Technology, Abbott Vascular Jie Hu, Manager, Material Characterization Lab and Bioanalytical Services, Abbott Vascular |
10:00 a.m. – 10:15 a.m. |
Break |
10:15 a.m. – 11:45 a.m. |
Purchasing Controls — Quality Begins With Procurement
Patti Gupta, President, Patti Gupta & Associates LL |
11:45 a.m. – 12:45 p.m. |
Lunch |
12:45 p.m. – 3:45 p.m. |
CAPA and Nonconformances — FDA Shouldn’t Be the Only Investigators
Gary Gilliam, Operations and Quality Executive, MedPharm Consulting, Inc. |
3:45 p.m. – 4:00 p.m. |
Break |
4:00 p.m. – 4:45 p.m. |
Managing Quality From The Top Down — Sustaining Overall GMP Compliance
Dr. Mary C. Getz, Vice President, NSF Health Sciences-Medical Device Consulting |
4:45 p.m. – 5:00 p.m. |
Conclusions and Acknowledgements Dr. Mary C. Getz, Vice President, NSF Health Sciences-Medical Device Consulting |
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