Get expert guidance on choosing on how best to integrate QbD, DoE and PAT into lifecycle approach to process characterisation.

A series of stimulating interactive lectures from experts in the field and teamwork activities will enable you 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.

The cost of the course includes tuition, course materials, lunches, refreshments and a networking dinner. Accommodation is not included.