European Aseptic Technologies & Annex 1 Conference

Registration

Objectives

This conference track gives you the opportunity to learn about the latest regulatory and technological developments in aseptic/sterile manufacturing and to discuss 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 revised EU GMP Directive Annex 1 was published in August 2022 after extensive discussions and came into force mainly in August 2023. Even two years later, there is still a need for discussion in various areas, as different authorities interpret the requirements differently and implementation in daily manufacturing still raises questions. From PUPSIT to CCS, questions arise as to who is affected, when exceptions can be made and to what extent previous practice can be adopted.

Target Audience

The event is aimed at experts and managers from the pharmaceutical industry as well as engineers and planners who have to deal with European Annex 1 and current aseptic technologies and control strategies in cleanrooms in their daily practice.