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Session 9 Track C: Combination Product GMPs
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 : At the conclusion 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 practice of handling adverse effects, usability, and complaints throughout drug/device lifecycle
- Describe challenges and opportunities in Supply Chain management
Speaker(s)
Speaker
Alan Stevens, MS
FDA, United States
Acting Division Director, Division of Drug Delivery, General Hospital and Human
Combination Products GMPs
James Wabby, MHS
AbbVie, United States
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
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