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  • Profile picture of cef3

    cef3 replied to the topic "Design Controls for Legacy Combination Products" – 5 years, 10 months ago

    I found a presentation that was put together by BioTechLogic to address this issue (http://c.ymcdn.com/sites/www.casss.org/resource/resmgr/2016_CMCS_TreDenickTracy.pdf). It seems like it is a very involved process and I’ve just listed the major steps below: 1. Quality System Gap Assessment 2. CAPA 3….   Read more»

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