QbD offers countless benefits, but obstacles still remain as drug companies struggle to fully understand and respond to regulatory uncertainty. This event is for pharma companies considering or already on the QbD trajectory, and provides pragmatic approaches to QbD implementation in a GMP environment.
Topics covered include:
- Improving Process Understanding
- Building Quality earlier in the Process
- Successfully Defining Criticality
- Executing a Successful QBD and PAT Deployment Strategy
- Translating established Development Practice into QbD
- Applying QBD to Biomanufacturing
Advancing QBD further than the design space
Fully optimising processes by implementing QBD earlier in development
Effectively de-coupling risk from criticality - using a risk based approach to assign criticality
Fully understanding FDA expectations on QBD and PAT and creating a strategy and successful implementation programme
Exploiting existing development practice and its transformation into QbD
