14.09.2017

Mainz: 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 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:

http://www.forum-institut.de/seminar/1709272-prozessvalidierung-aktuelle-anforderungen-fuer-cmc

(Conference organized by FORUM Institut)

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  • 10.03.2017
    News for the Industry
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  • 26.07.2013
    News on Change Control/Variations:
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  • 31.01.2013
    EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
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EU: New Variation System in force as of Jan 1, 2010. Filing of variations will be faster, easier, and more flexible. Have you considered that your Change Control System needs to be updated accordingly?
EU: Centralised Marketing Authorisation Procedure for ATMPs needed Have you already filed your application? The time clock is ticking. Transitional periods will be over soon.
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