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?