04.-05.11.2020

Live Online Training: 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.

Due to the COVID-19 pandemic this course is now offered as live online training.


(Conference organized by Concept Heidelberg)


Back

HOTLINE

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

Events

  • 18.-19.06.2024
    Online Seminar: Der Regulatory Affairs Manager
    More
Get all events



News

  • 19.12.2022
    EU Update regarding Deadlines of Nitrosamine Impurities
    More
  • 01.09.2022
    EU-GMP Annex 1 finally published
    More
  • 26.08.2022
    New Deadlines and Chances for Nitrosamines
    More
Get all news