The course will be an interactive lecture around Pre-filled Syringe Systems including ISO compliance testing. The participants will benefit from first hand information of both lecture leaders based on practical experience. The lecture includes the life cycle of a PFS from the idea to the finished marketed product.
Who Should Attend
The course is designed specifically for those who are involved or interested in the development, manufacturing and QC-testing of a Pre-filled Syringe System:
- Engineers and Managers in Device Development and all other technical functions surrounding syringe systems
- Manufacturing Supervisors
- Quality Personal / Regulatory Personal
- Clinical and commercial Drug Product Manufacturing
Upon completion of the course the participants will have solid knowledge of
- Materials used for PFS Systems
- Luer Cone and Luer Lock Compliance Testing
- Requirements for the empty sterile sub-assembled syringe ready for filling
- Test Methods for Drug Product Filled Syringes
- PFS used in Delivery Systems
Horst Koller, CEO, HK Packaging Consulting
Prior to becoming a consultant, Horst worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 20 years industry experience. His consulting company is focusing on Technical, Regulatory and QM-Support around Primary and Secondary Packaging Systems including Medical Devices. He is an active member within the technical ISO Committees TC76 and TC84 as well as an active speaker on international conferences. He holds an Engineering degree in Biotechnology from the University of Applied Sciences in Mannheim / Germany.