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Hyatt Regency Bethesda

2015 年 04 月 13 日 7:00 上午 - 2015 年 04 月 15 日 12:00 下午

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

CMC Workshop 2015

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Session 6A: Process Validation/Verification - Chemicals

Session Chair(s)

Kevin Seibert, PHD, MS

Kevin Seibert, PHD, MS

Engineering Fellow, Synthetic Molecule Design and Development

Eli Lilly and Company, United States

With the changing landscape of small molecule syntheses, and the implementation of many Quality by Design principles into the drug development as well as commercialization activities, traditional approaches to process validation may not provide a sufficient data package or confidence to ensure robust long term manufacture. Infrequent production, desired flexibility, and alternative synthetic platforms (i.e. flow chemistry) offer unique challenges and therefore validation or ongoing verification strategies that support these activities need to be considered. This session will provide examples of validation and verification strategies useful for addressing the changing regulatory landscape. Time will be reserved for a panel discussion and audience participation is highly encouraged.

Speaker(s)

Kevin Seibert, PHD, MS

Validation Challenges of a Small Molecule Flow Chemistry Process

Kevin Seibert, PHD, MS

Eli Lilly and Company, United States

Engineering Fellow, Synthetic Molecule Design and Development

Christine Capacci-Daniel, PHD

FDA Perspective

Christine Capacci-Daniel, PHD

FDA, United States

Consumer Safety Officer, Office of Process & Facilities, OPQ, CDER