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The Impact of Cell Bank Establishment

The Impact of Cell Bank Establishment

2022-08-03

For products made from cells, cell bank characterization is a crucial quality-control procedure. A well-established cell bank is essential to guarantee there is an appropriate supply of similar cells for use for the course of the product's complete life span once a cell line is selected as its biological source. 





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Entry Level CMC - EU edition MasterClass

Entry Level CMC - EU edition MasterClass

12-13 December, 2022

The Entry Level CMC Masterclass covers the general requirements for small molecules and biologics.

ICH Q10: How to manage your Quality System including Quality KPIs - EU edition MasterClass

ICH Q10: How to manage your Quality System including Quality KPIs - EU edition MasterClass

12-13 December, 2022

This MasterClass is completed by fundamentals of an appropriate Quality Culture which constitute the basis for a successful PQS - besides all regulations.

Risk Management plans and its Implementation - EU edition MasterClass

Risk Management plans and its Implementation - EU edition MasterClass

12-14 December, 2022

The aim of a Risk Management plans and its Implementation Masterclass is to document the risk management system considered necessary to identify, characterise and minimise a medicinal product’s important risks. 

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