This webinar will update on the current status and give an overview of the modifications that have been implemented compared to the 2017 version. Furthermore, it will give some hints how review groups see the updates and which concerns are still persistent.
- General view of Review Groups
- positive aspects
- “difficult” aspects
- Specific requirements and aspects regarding (examples):
- Barrier technologies
- Cleanroom classification and qualification
- Trending requirements in EM and personnel
- Aseptic process simulation (media fills)
- Quality control – sterility testing
Recording from 30.04.2020
Duration of recording: 1,5 h.