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Radisson Blu

Jun 20, 2018 7:45 AM - Jun 21, 2018 5:00 PM

Steinentorstrasse 25, 4001 Basel, Switzerland

DIA CMC Workshop

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Session 2B: Process Validation/Process Verification

Session Chair(s)

Andrew Chang, PHD

Andrew Chang, PHD

Sr. Quality and Regulatory Compliance Director, Novo Nordisk A/S, United States

There is a lack of clear, comprehensive harmonised guidance on process validation for drug substance and finished pharmaceuticals. In this session, participants will hear both an industry and regulatory viewpoint on globally harmonised expectations including some possible opportunity areas to address current perceived challenges and opportunities for improvement. Additionally, Process Validation considerations for new manufacturing technologies, e.g. Continuous Manufacturing will be discussed.

Speaker(s)

Jens Peter Gundorf

Jens Peter Gundorf

Principal Validation Specialist, Novo Nordisk A/S, Denmark

Christoph Wabel, PHD, MBA

Christoph Wabel, PHD, MBA

Director/Team Leader Process Management, Product and Process Development, Pfizer, Germany

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