The technological developments and the new regulations have a strong impact on the pharmaceutical manufacturing. In this conference we focus on the aseptic processing, especially fill finish operations of biopharmaceuticals.
Conference Discussions will include:
A Regulatory update: What is new in the draft Annex 1? This has an impact on European manufacturer but also on the member countries of PIC/s. Inspectors from Europe and Korea will share their perspectives and discuss the potential impact on aseptic manufacturing
The environment of aseptic manufacturing: What are most advanced technical solutions from barrier systems, contamination control, cross contamination avoidance, testing and unit operations
Fill-finish operations: Standard filling lines, robotic systems, qualification, process simulation and regulatory aspects
Pharmaceutical Product quality testing: The technologies on visual inspection and container integrity, the current regulatory trends will be highlighted
The Conference will close with a panel discussion focusing on the future of fill-finish operations.
In addition there will be an exhibition at the conference and several training courses.