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MedIQ Consulting talar på ISPE Nordic

Den 26 maj 2016 kommer MedIQ Consulting medverka på ISPE Nordic konferens. ”EU GMP Annex 15 Qualification & Validation and Continuous Process Verification”. Läs mer om konferensen här

Utdrag från programmet: ”EurdraLex Volume 4, Annex 15 ”Qualification and Validation” has been updated and was effected 1 October 2015. The previous version of Annex 15 of the EU Guide to GMP was published in September 2001, and since then there have been significant changes in the GMP environment and there have been advancements in manufacturing technology and continuous manufacture processes. Guidelines from the International Conference on Harmonisation (ICH), US FDA Guide on Process Validation, as well as the approaches in ASTM E2500-07 ”Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment” have also justified the change. This presentation will give you the major changes and additional section in the updated version of Annex 15.”


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