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F47 MBI: Quality by Design of Effective Bioprocess Characterisation & Validation 2023

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Event Information

Quality by Design
Dates of Event
20th March 2023 – 23rd March 2023
Last Booking Date for this Event
15th March 2023

Description

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.

https://www.ucl.ac.uk/biochemical-engineering/research/mbi/courses/vb

Attendee CategoryCost   
Standard.£1750.00[Read More]

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