12.06.2017

Berlin: Outsourcing from API to Drug Product - (GMP and regulatory Perspective in EU and US)

This course will focus on individuals that have input into supply chain management decisions, or who have oversight or actively manage technology transfers in EU or US. Particularly, Dr. Hiltrud Horn will give detailed insight into outsourcing strategies for EU and US, from both perspectives, QC and QA. Furthermore she will guide you through the process transfer of drug substances and drug product. In a specifically tailored workshop she will show you the essentials of the project management for a typical technology transfer project. Upon completion of this workshop you will be able to set up your supply chain successfully, understand the essential principles for starting outsourcing activities and know the necessary GMP and regulatory background.

For more information please visit the following website:
https://www.pda.org/global-event-calendar/event-detail/supply-chain-strategies-for-api-and-drug-product


(Conference organized by PDA )



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    News on Change Control/Variations:
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    EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
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EU: New Variation System in force as of Jan 1, 2010. Filing of variations will be faster, easier, and more flexible. Have you considered that your Change Control System needs to be updated accordingly?
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