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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
12-13 December, 2022
The Entry Level CMC Masterclass covers the general requirements for small molecules and biologics.
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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.
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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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