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Radisson Blu

2018 年 06 月 20 日 7:45 上午 - 2018 年 06 月 21 日 5:00 下午

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

Vice President, Quality and Regulatory Compliance

Novo Nordisk, 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

Robust and Lean Process Validation - Compliant with Regulatory Requirements: Novo Nordisk as a Case Study

Jens Peter Gundorf

Novo Nordisk A/S, Denmark

Principal Validation Specialist

Christoph Wabel, PhD, MBA

Practical Considerations Towards Process Validation for Continuous Manufacturing (PCMM)

Christoph Wabel, PhD, MBA

Pfizer, Germany

Director/Team Leader Process Management, Product and Process Development