Quality by Design (QbD)
The Chocolate Risk Assessment as teaser
Teaching QbD best starts with the famous 1h "Chocolate risk assessment presentation" - intentionally using an example from outside pharma. This is a fun and easy to digest introduction to the world of Quality by Design.
You will learn about:
- The intention and the starting points: Who defines Quality?
- Voice of the Customer
- Critical Quality attributes
- historic (previous) knowledge
- Critical Process Parameters
- DoE (Design of Experiments)
- Risk assessment at various levels
- Control Strategy
Quality by Design training
While the chocolate risk assessment gives a nice and compact overview about Quality by Design, there is so much more to discover which will be covered during the QbD training in depth:
- The intention and the starting points: Who defines Quality?
- Voice of the Customer
- Target Product Profile (TPP)
- Quality Target Product Profile (QTPP)
- Regulatory guidelines and requirements like ICH Q8, Q9, Q10 etc.
- Critical Quality attributes
- Previous knowledge
- Critical Process Parameters
- Various Risk assesment tools like FMEA, HAZOP, Fishbone Diagram, Single Risk assessments
- Risk assessment at various levels
- Control Strategy
- feedback loops and communication
One very important component of QbD is Design of Experiment (DoE), which is a course by itself.