10-11 December 2019
Radisson Blu Edwardian Grafton,
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
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 experienced professionals 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?
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)
Understand the physicochemical and biological analytical tools available to monitor the impact of process change
Hear about the non-clinical and clinical testing programmes that might be required to support major process change
Analyse the US and EU regulatory requirements following process change
Who is this course for?
This course is suitable for anyone working in:
- Regulatory affairs
- Quality assurance
- Project managers
I enjoyed the insight we were given from actual projects and the case-by-case discussions.
There was great interaction during the course as there was a small group and the open discussion was invaluable.
Ganymed Pharmaceuticals AG
The course was perfect. There was a good balance between the theory of comparability and material exercises.
The practical sessions were very useful and the course content was excellent.
Global Regulatory Affairs