Professional Training
4.6 (8 Reviews)

Introductory Level CMC Analytical, Comparability & Stability Testing and Lab Practices for Biotechnology and Biosimilar Products

PTI, In London
2 days
2 days
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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:


85% had applied content during the course to their role

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Average rating 4.6

Based on 8 reviews.
Reviews are published according to our review policy.
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Analytical Development Manager, Rottapharm Biotech
23 Jun 2020
Easy to understand

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.

Responsible Analyst, Covance
23 Jun 2020
Answered my questions

An excellent course which answered a lot of questions and concerns

Principal Pharmaceutical Scientist, Medicines and Healthcare products Regulatory Agency
07 Apr 2017
Excellent course

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...

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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.

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