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Starting 8-9 November 2021
2-day live online training course running daily from 8am-2pm EST
Starting 8-9 November 2021

2-day live online training course running daily from 8am-2pm EST

Gain an understanding of regulatory and technical considerations to help you manage process change in the manufacture of biologics

Course Overview

Process changes made during the manufacture of recombinant proteins can have profound implications. This 2-day course provides valuable insight into the quality, safety, efficacy and regulatory impact of manufacturing changes and how to manage process change to guarantee regulatory compliance and product consistency at all times. 

It features numerous case studies from industry and practical advice from our expert instructor on the best ways to satisfy the needs of the regulators. You will also learn how various process changes may impact the success of your products.

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


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?

This course is suitable for anyone working in:

  • Manufacturing
  • Analytics
  • Regulatory affairs
  • Quality assurance
  • Project managers



Michor Consulting

I enjoyed the insight we were given from actual projects and the case-by-case discussions.

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.