30.09.2016

Frankfurt: Prozessvalidierung - Update für CMC

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 dossier requirements on process validation (applicable since August 2014) and the revision of the EU GMP Guide annex 15 (applicable as of October 2015) 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:

http://www.forum-institut.de/index.php?id=665&L=0&no_cache=1&tx_ttnews[tt_news]=1609270

 

(Conference organized by FORUM Institut)



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