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?
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
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.