(0)

DIA会员及用户请点击登录

登录

忘记用户 ID？ or 忘记密码？

Not a Member?

创建账户并加入。

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

返回 Agenda

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

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

Christoph Wabel, PHD, MBA

Christoph Wabel, PHD, MBA

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

Practical Considerations Towards Process Validation for Continuous Manufacturing (PCMM)

获得信息并保持参与

不要错失任何机会——请加入我们的邮件列表，了解DIA的观点和事件。