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:
https://www.gmp-compliance.org/training/gmp-course-conference/how-to-provide-process-validation-data-in-a-regulatory-submission

(Conference organized by Concept Heidelberg)

HORN Pharmaceutical Consulting
CMC – GMP – Regulatory Affairs
Dr. Hiltrud Horn
Am Alten Schloß 1
D-76646 Bruchsal
Germany

Phone: +49 (0) 7251/305 527
Fax: +49 (0) 7251/305 528
Mobile: +49 (0) 160/5834 213
e-mail: info@horn-pharma.de
Internet: www.horn-pharma.de