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Generic Inspection  Form

Generic Inspection Form

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Instructions and help about Generic Inspection

thanks for the kind introduction i am hai tao lee from office of pharmaceutical manufacturing assessment in this presentation my colleague dr gantarov and i will discuss using of alternate tools for inspection during the coding 19 pandemic i will first discuss our office general approach to manufacturing assessment followed by discussing the implementation of alternate tools to assess facilities during code 19. specifically i will talk about 704 a4 record requests and in the second part of this presentation alex will cover remote interaction evaluation in short rie since some o4a4 record request has been discussed in a previous sbia meeting the focus of today's presentation is more on rie fda rie guidance is out since last april our office has been using this tool to enhance record requests after the guidance is published alex will wrap up the talk with a few concluding remarks our office takes a holistic manufacturing assessment of our application to ensure quality products av

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