Course description
Comparability for Biologics - 2-day training course by Pharmaceuticals Training International
The quality, safety, efficacy and regulatory approval of your biopharmaceuticals is strongly connected to the process changes during the manufacture of recombinant proteins. This essential two-day course gives you a practical insight into how to manage process change so as to ensure regulatory compliance and product consistency throughout the process.
This course illustrated comparability best practice using more than 20 industry case studies, enabling participants to find the best ways to satisfy the needs of the Regulators. At the end of the two-day course, participants will have a clear understanding of the various process changes which may impact the success of their products.
Do you work at this organisation and want to update this page?
Is there out-of-date information about your organisation or courses published here? Fill out this form to get in touch with us.
Suitability - Who should attend?
This training course is aimed at professionals specialising in Biopharmaceuticals.
Training Course Content
This two-day programme for professionals in Biopharmaceuticals will cover:
- The inter-relationship between process change, quality, safety and efficacy
- The importance of change control, Good Manufacturing Practice (GMP) and the potential of Process Analytical Technology (PAT)
- The potential significance of various process changes and how these may impact the quality of your products
- The physiocochemical and biological tools available to monitor the impact of process change
- Non-clinical and clinical testing programmes that might be required to support major process change
- The US and EU regulatory requirements following process change
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5
Reviews
Average rating 5
There was great interaction during the course as there was a small group and the open discussion was invaluable
The course was perfect. There was a good balance between the theory of comparability and materical exercises
Expenses
The cost of this training course is £1595 + VAT per participant, which covers tuition and course materials.
In-house Training
PTI - Pharmaceutical Training International can also deliver this course as in-house training for your company. You can reduce costs, enhance accessibility to training resources and better address your company’s own business goals with a tailored PTI training package.
I enjoyed the insight we were given from actual projects and the case-by-case discussions