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 as of August 2014 will be presented. 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. Furthermore, Dr. Horn will present typical pitfalls and how to avoid them.
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(Conference organized by FORUM Institut)