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Informa

10-11 December 2019
Radisson Blu Edwardian Grafton,
London

Comparability for Biologics

Gain an understanding of regulatory and technical considerations to help you manage process change in the manufacture of biologics on this 2-day course

Course Overview

What will you learn?

Process change

Gain insight into the inter-relationship between process change, quality, safety and efficacy - you will discuss the potential significance of various process changes and how these may impact the quality of your products


GMP

Examine the importance of change control, Good Manufacturing Practice (GMP) and the potential of Process Analytical Technology (PAT)

Analytical tools

Understand the physicochemical and biological analytical tools available to monitor the impact of process change

Testing programmes

Hear about the non-clinical and clinical testing programmes that might be required to support major process change

Regulatory requirements

Analyse the US and EU regulatory requirements following process change

Who is this course for?