This 4 day course. made up of lectures from experts in the field and teamwork activities, will enable participants to:
- Learn about the latest FDA and EMEA regulations with regards to QbD, PAT, process characterisation and validation.
- Understand current and future perspectives of the impact of QbD and PAT on the effort required for process characterisation.
- Learn how to perform Risk Assessments to determine Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).
- See examples of how to combine scale-down models with historical knowledge and DoE to map out Design Space.
- Understand the principles behind the characterisation and validation of unit operations, such as fermentation, filtration, chromatography, formulation through to supply chain logistics.
- Learn how to apply QbD to continuous operations, e.g. perfusion culture and filtration operations.
- Explore the impact of single-use components on validation needs
- Apply QbD when implementing pre/post-approval process changes.
- Network with sector leaders and subject matter experts.
This module is suitable for scientists and engineers working in the biotech sector that are involved or liaise with people in Process Development, Process Characterisation, Validation, Manufacturing, Quality and Regulatory activities.
Emphasis is on teaching through interactive problem solving case studies in small classes for effective learning. Each course is UCL-accredited and can be taken individually or combined for a Masters level qualification.
