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Session 3: Linking Pharmaceutical Development to the Design Control Process
Session Chair(s)
James Wabby, MHS
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
AbbVie, United States
One impact of the combined quality system under 21 CFR Part 4 is the demand for design control when developing a combination product. The implementation of a complete design control process should follow the waterfall model as described in the FDA’s design control guidance for a medical device manufacturer. However, it is a challenge to transfer all these new terms within design control to their existing and traditional pharmaceutical development processes.
Learning Objective : At the conclusion of this session, the participant should be able to:- Interrelate pharmaceutical development practices to demonstrate design control compliance
- Outline best practices in developing a design and development plan to describe device and pharmaceutical development interfaces
- Describe challenges and opportunities maintaining a Design History File (DHF) to leverage and cross-reference developmental data and systems
Speaker(s)
A Systems Approach to Combination Product Development
Daniel Becker
Teva Pharmaceuticals, United States
Associate Director, Global Device R&D Operations
A Systems Approach to Combination Product Development
Karthik Balasubramanian, PhD, MS
Verrica Pharmaceuticals, United States
VIce President, CMC & Technical Operations
Linking Pharmaceutical Development to Design Control: Connected Combination Products
Lori-Ann Archer
Independant Consultant, United States
Medical Device and Combination Products QMS Expert
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