25.08.2020

Online Seminar: Prozessvalidierung - Aktuelle Anforderungen an CMC-Daten

In this training course, Dr. Hiltrud Horn will give detailed insight into the new concept of process validation and the essentials to be considered for the CTD. The latest dossier requirements on process validation and the impact of the revised EU GMP Guide annex 15 will be presented. Dr. Horn will show what is important for Regulatory Affairs. In addition, regulatory expectations for biotechnological derived drug substances will be highlighted. In the workshop you will discuss project planning including validation strategies. Furthermore, you will learn what is needed for regulatory submissions (CTD) and what is relevant for inspections. Additionally, Dr. Horn will present typical pitfalls and how to avoid them.

Due to the COVID-19 pandemic this course is now offered as an online Seminar.


(Conference organized by FORUM Institut)


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