23.10.2013
Mannheim: Kompaktwissen pharm. Qualität für Zulassungsmitarbeiter
In this specifically-tailored training course for Regulatory Affairs people, Dr. Hiltrud Horn will provide you with the essentials for the Quality Part of the CTD. She will talk about setting the right specifications as well as deciding about the necessary details in analytical methods and validations. She will advise you on the important aspects of packaging material and stability studies.
Furthermore, you will learn about active pharmaceutical ingredients (APIs) and when to use an ASMF/CEP/US-DMF. In specific case-studies you will get detailed insight on strategies for efficiently writing the quality part of the CTD and how to avoid pitfalls and unnecessary variations.
For more information please visit the following website:
http://www.forum-institut.de/fileadmin/scripts/php/downloader/pdf_download.php?downloadid=1310265
(Conference organized by Forum Institut)
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