Course description
Introductory Level CMC Analytical, Comparability & Stability Testing and Lab Practices for Biotechnology and Biosimilar Products
This two-day training course will provide delegates with a clear, concise, but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful design, implementation and documentation of the required CMC analytical and stability studies for biotechnology products, which include emerging biosimilar products.
Key deliverables from each phase of development will be illustrated. Current ‘hot-button’ CMC analytical and stability issues will be presented, as will strategies for preventing (or remediating) gaps will be presented.
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Suitability - Who should attend?
This training programme is aimed at professionals specialising in Biopharm operations within the pharma industry.
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 4.6
An excellent course which answered a lot of questions and concerns
Nadine has an open, friendly approach and encourages participation and discussion. The content was aligned with my needs, coupled with a positive review from a colleagues who ha...
Expenses
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.
Nadine was really clear, it is evident that she really knows the object of this course. By using examples, she made everything really easy to understand.