28.-29.11.2017
Vienna: Setting Specifications and Acceptance Criteria
Dr. Horn will explain strategies defining specifications for excipients and container closure systems in EU and US. Her presentation will cover the essential aspects for setting the right specifications in the CTD.
Furthermore, you will learn what needs to be considered in a global environment and what are the typical questions and challenges relating to excipients and the container closure system that CMC-people have to deal with. In the afternoon, Dr. Horn will proceed with her presentations on the combined conference “Stability Testing for Drug Substances and Drug Products”.
For more information please visit the following website:
https://www.gmp-navigator.com/daten/seminarpdf/ECA-Setting-specifications-2017.pdf
(Conference organized by Concept Heidelberg)
Back 