Berlin: How to provide process validation data in regulatory submission

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. 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:

(Conference organized by Concept Heidelberg )



Phone +49 (0) 7251/305 529
Fax +49 (0) 7251/305 528


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    Mannheim: Aktuelle Trends in der Qualitätskontrolle
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  • 10.03.2017
    News for the Industry
  • 26.07.2013
    News on Change Control/Variations:
  • 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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