Summary
This training course provides an in-depth analysis of aseptic filling, one of the most challenging process steps in fill & finish of liquid formulated, biopharmaceutical drugs or lyophilized biopharmaceuticals. The training will offer real life examples and best practices for aseptic filling process management, qualification, validation & enviromental monitoring, plus digital networking time with industry peers.
Who should attend?
- Heads of production
- Shift leads
- QA reps or shop floor QA
- Project managers
- Operators in aseptic filling or visual control
Learning Objectives
- Three interactive workshops and group exercises
- Learn what are the causes for contaminations in an aseptic filling process
- Development of a fictive aseptic filling process (what technology is used, which equipment and assignment of the requirements?)
- Let’s build an aseptic filling facility, what are the main areas to be considered?
- How to set up a holistic aseptic filling concept?
Key Topics
- Aseptic filling process management
- New requirements by EMA and Annex 1
- Holistic concept, techniques, interfaces
- Validation and re-validation of aseptic filling steps
- Environmental Monitoring
- Visual control
- Failure investigation & Practical tips
- Examples of FDA findings for contaminations in aseptic products
Programme
- Training materials will be provided in digital form
- All delegates will receive digital and LinkedIn certificates
Trainers
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