European Aseptic Technologies & Annex 1 Conference

Objectives

This conference track provides a valuable opportunity to gain insight into the latest regulatory and technological developments in aseptic/sterile manufacturing. Additionally, it offers a platform for constructive dialogue on the current interpretation of the guidelines with colleagues and regulatory representatives. You will also gain insight into the technical implementation of production requirements in sterile manufacturing and the difficulties that can arise. Case studies from the industry will introduce you to approaches and solutions that may provide inspiration for your own implementation.

Background

The EU GMP Directive Annex 1 was revised and published in August 2022 following extensive discussions, and came into force primarily in August 2023. Despite the passage of two years, various areas still require further discussion due to differing interpretations of the requirements by different authorities and ongoing questions regarding implementation in daily manufacturing. From PUPSIT to CCS, questions have been raised regarding the affected parties, the circumstances in which exceptions can be made, and the extent to which previous practices can be adopted.

Target Audience

The event is designed for experts and managers in the pharmaceutical industry, as well as engineers and planners who are responsible for implementing European Annex 1 and current aseptic technologies and control strategies in cleanrooms in their day-to-day work.

 

You can find more detailed information at a later time.