Annex 1 - Implementing Contamination Control Strategy Effectively

The new Annex 1 has caused a lot of uncertainty. Many users do not know how to implement the various inspection-ready requirements. We want to give you confidence through this seminar that you can meet the Annex 1 requirements for your processes and also for you as a supplier with your systems and equipment in a risk-based manner.

Within the framework of a well-implemented contamination control strategy, we will show you how to integrate existing measures, protection concepts, risk assessments, etc., into this framework. In workshops, we will have time to discuss "Learnings from Annex 1" together and benefit from them.

The efficient integration of QA oversight into your process will be presented to you. Likewise, the most important changes in Annex 1 will be explained so that you can subsequently review your process through a GAP analysis. For example: How are sterilizing filters tested? What are the requirements for PUPSIT?

What about media fill or aseptic process simulation? What do you need to consider? The same applies to the requirements for aseptic manufacturing or final sterilization. We will show you how to implement all of this in a meaningful way.