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Data Trending-Alert/Action Level Settings EU GMP Annex 1, Rev. 12 Draft

In this brief video, Daniele Pandolfi discusses the Annex 1 draft and some of the aspects that can be used to understand the current state of regulatory positioning. It covers Trending Relevance (current Annex 1 vs Rev 12 Draft), Environmental Trends (approaches and procedures), and Level Settings (definition and process). The new Annex 1 draft addresses the gaps with data analysis and trends.

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