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Session 3: Combination Products Lifecycle Management Issues Today
Session Chair(s)
James Wabby, MHS
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
AbbVie, United States
Combination products are a hot topic in healthcare. While these products open doors to exciting new possibilities, they also bring new challenges. This session will discuss the importance of promoting a culture of compliance to build a compliant lifecycle management infrastructure around combination products to ensure appropriate cGXPs and Quality System regulations are enforced throughout the franchise. Open discussions and dialogue will be included.
Learning Objective : Upon completion of this session, participants should be able to:- Identify key aspects in implementing a QMS for a drug/device product per 21CFR Part 4
- Identify key focus points in the drug/device design control process
- Outline best practices of handling adverse effects, usability, and complaints throughout the drug/device lifecycle
- Describe challenges and opportunities in Supply Chain management
Speaker(s)
Combination Products Lifecycle Management Issues Today
Vijay Damodaran
Eli Lilly & Company, United States
Advisor/Director, Global Quality
Lifecycle Management
Alan Stevens, MS
FDA, United States
Acting Division Director, Division of Drug Delivery, General Hospital and Human