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.
To learn more and register for the course, please click here.