Annex 1: Catching up with the new guidelines – what to be aware of?
About the seminar
After many years, the long awaited revised Annex 1 on manufacturing of sterile medicinal products has been released and with the upcoming deadline of the 25th august. The additions are aimed to improved protection of product, and the requirements for seasonal and routine monitoring are seeing much more attention. As a part of the new regulations the Contamination Control Strategy (CCS) is implemented across the facility to help minimize the risk of contamination and protect the product quality. So which considerations is there in the regards to monitoring and aspects such as product contact, contaminations, raw material quality and product protection?
Topics
The following topics are some of the ones that will be touched upon in this seminar: CCS, Cleaning and disinfections agents, Environmental Monitoring, Raw materials, Gas, Water & Container Closure Integrity Testing (CCIT).
Who should attend?
This event is aimed for anyone working in a QC or QA wanting to gain knowledge on which changes the revised Annex 1 brings to product protection
When?
May 31st 2023
13:00 - 15:30 (CET)
Where?
Eurofins BioPharma Product Testing Denmark A/S, Ørnebjergvej 1, 2600 Glostrup, Denmark
Speaker
The speaker, Aske Lundbo Andersen, works as a Process Control and Validation Scientist at Eurofins BioPharma Product Testing Denmark. He has a background as chemical engineer and has former experience with teaching in the STEM field. At Eurofins he is working on qualification projects and testing/sampling within process control.