Target Audience

This event is aimed at the following individuals:

– Specialists and managers in sterile pharmaceutical production
– Employees from Quality Assurance (QA) and Quality Control (QC)
– Experts in aseptic manufacturing and filling
– Engineers and technicians in plant planning and operation
– Project managers responsible for new builds, retrofits, or modernization of filling lines

In certain cases, participation in the event may not be possible due to competitive reasons!

Objectives

Sterile filling has undergone a fundamental development in recent years: increasing regulatory requirements, growing product complexity, and the trend towards closed, automated systems are shaping modern sterile production.

Especially the requirements from EU GMP Annex 1 have significantly intensified expectations regarding plant concepts, processes, and quality monitoring. Topics such as Contamination Control Strategy (CCS), First Air, barrier systems (RABS/isolators), and decontamination are now central to inspections and operational decisions.

The aim of this event is to bridge the gap between regulatory requirements and technical implementation in modern filling. Participants will gain a solid understanding of current GMP expectations and learn how to practically translate these into concrete plant concepts, process designs, and operational strategies.

Both existing systems (e.g., through retrofitting) and new technological approaches such as mobile robotics or glove-free production will be considered. The goal is to provide practical solutions to make aseptic processes efficient, compliant, and future-proof, as well as to confidently pass inspections.