The final version of the revised Annex 1 was published on 25 August 2022, some seven years after the revision process started. Join our virtual instructor-led course on 25 October to ensure that your contamination control strategy meets the requirements of EU GMP Volume 4 Annex I.

ABOUT THE COURSE

This one-day course takes a deep dive into how you can develop a contamination control strategy to help you mitigate risk and improve product quality. You will gain insight into how to generate an end-to-end pharmaceutical contamination control strategy that balances precautions to risk.

KEY LEARNING OBJECTIVES

• An overview of changes in the new Annex I as well as their implications and how to interpret them
• Team creation, methodology, format and content in preparing the CCS (we provide a detailed guide)
• Expectations of regulatory bodies regarding the CCS and how they will use it to assess compliance with the cGMP of your sterile facility.