01. – 02.12.2015
Berlin: How to provide process validation data in regulatory submissions
On December 01, 2015 Dr. Hiltrud Horn will provide the basics that CMC-people should know about process validation. You will get detailed insight into the traditional process validation and new concepts of continuous process verification. You will learn about the key-aspects to be considered from development to submission of your CTD. Get the chance and discuss the challenges and opportunities of your validation projects with the speaker. She will present case studies on typical validation projects and you will learn how to select the best validation strategy depending on your type of product. On December 02, 2015, you will discuss typical examples on site and process changes which validation data are needed. Learn how to efficiently handle post approval changes.
For more information please visit the following website:
http://www.gmp-navigator.com/daten/seminarpdf/ECA-How-to-provide-Process-Validation-Data.pdf
(Conference organized by Concept Heidelberg)
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