Preparing the CMC Section for NDAs/CTDs/INDs
15 March 2010 - 16 March 2010
Presented by: The Center for Professional Innovation & Education   -   Location: Costa Mesa, CA USA
Contact: Michael Roberts  info@cfpie.com -  610-688-1708    http://www.cfpie.com/showitem.aspx?productid=061&source=gxp

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This course will provide participants with a thorough understanding of the requirements for each CMC/Quality section of the Common Technical Document (CTD), the format to be used for NDAs, including preparation of the Quality Overall Summary (Module 2). It will also present techniques for making the CMC submission easy to review, including sample tables and figures, and discuss how to address issues during CMC meetings with the FDA and review questions.