Stream: Quality Systems, Documentation & Quality by Design
A concentrated introduction to validation strategy and the Quality by Design principles that determine whether a process is controllable before it is validated.
Learning Objectives:
- Outline a validation strategy appropriate to an advanced therapy process
- Apply Quality by Design thinking to define critical quality attributes and process parameters
- Recognise where inadequate design, rather than inadequate execution, causes validation failure
Modules:
- Planning a Validation Strategy
EST. COMPLETION 30 MIN - E-learning format