Annex 1 – Final Version and its Impact – Live Online Conference

This conference offers you a unique possibility to become acquainted with the new regulatory requirements of the revised  final Annex 1, the impact on aseptic manufacturing and the challenges relating to quality aspects.

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.