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hello and thank you for the opportunity it is my great pleasure to tell you about our ongoing initiative in the office of pharmaceutical quality named knowledge aided assessment and structured application also known under the acronym of casa i have to say that in my 10 years at fda i worked on many initiatives but casa is the one that iamp;#39;ve been the most excited about and i consider myself lucky to have been part of since the very beginning of it this is a project that obq has been working on since 2016 that recently started to receive an increased visibility so about a year ago given the progress that we made in casa for genetics we also became interested in modernizing the drug substance assessment through casa and so today you will be hearing through this presentation what casa is factors that prompted the development of casa and i will then illustrate the major milestones of casa initiative and how they impact the drug substance assessment moving forward and also highlight t
