Introduction and Organisationals
General Introduction on Risk Assessments
- Principles of ICH Q9
- Patient safety and product quality
- Dos and don’ts
- Tools and methods
ICH Q8, Q9 and Q10 Principles
- Quality by Design (QbD)
- Criticality of quality attributes and process parameters
- Control strategy life cycle
- Knowledge management
How to Apply Risk Assessments in Contamination Control
- Pro-active vs. reactive
- FMEA for equipment and processes
- Risk assessments for impact assessments
- HACCP for contamination control
Example of a Contamination Control Strategy
- Contamination control master file
- Reference document
- Annual report
Short Interactive Session (participants do an FMEA on a certain topic)
- Executing an FMEA (on a sterilizer or isolator)
- Evaluation – what went well and what were the challenges?
Evaluation and Conclusion / Q&A Session