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Annex 1 – Final Version and its Impact – Live Online Conference
December 14, 2022 @ 8:00 am - December 15, 2022 @ 5:00 pm
Authority speakers as well as representatives from pharmaceutical industry and experts from technical suppliers will provide you information about their thinking about the new requirements. They will discuss the statements of the new Annex 1 on topics like Quality Risk Management, Process Simulation/Media Fills well as the challenging topics of PUPSIT and the use of Single Use Materials.
The widely discussed topic of Contamination Control Strategy will also be discussed and the updated ECA Guide will be presented in support.
Subsequently, classical topics of contamination control like environmental monitoring and cleaning and disinfection are considered in the light of Annex 1.
- TCCS and its parts – from MSC up to Monitoring
- The benefits o a risk-based system- from DI up to trending
- Takeaway Tools
- Digitization in quality management and contamination control
- Remote and hybrid work
- Integrated Metrics
- Process flow metrics and KBIs