UCL DEPARTMENT OF BIOCHEMICAL ENGINEERING

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 studies.
Understand how to adopt a lifecycle approach to process characterisation and validation to obtain deeper process understanding.
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 and chromatography.
Select appropriate techniques to validate cleaning of bioprocess equipment and determine whether disposable components are an option.

Who should attend?

This module is suitable for scientists and engineers working in the biotech sector that are involved or liaise with people in the Process Development, Process Characterisation, Validation, Manufacturing, Quality and Regulatory activities.

For further information please email Dr Karen smith at karen.smith@ucl.ac.uk or see http://www.ucl.ac.uk/biochemeng/industry/mbi/courses