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.

For more information please visit the following website:
https://www.forum-institut.de/seminar/2008272-prozessvalidierung-anforderungen-an-cmc-daten

(Conference organized by FORUM Institut)

HORN Pharmaceutical Consulting
CMC – GMP – Regulatory Affairs
Dr. Hiltrud Horn
Am Alten Schloß 1
D-76646 Bruchsal
Germany

Phone: +49 (0) 7251/305 527
Fax: +49 (0) 7251/305 528
Mobile: +49 (0) 160/5834 213
e-mail: info@horn-pharma.de
Internet: www.horn-pharma.de