Preparing the CMC Section for NDAs-CTDs-INDs
June 25 - 26, 2012 - King of Prussia PA US
Center for Professional Innovation and Education, Inc.
Phone: (610) 688-1708
This course is designed for personnel involved in preparing the chemistry, manufacturing and controls (CMC) section of a NDA or IND in CTD format. Participants will gain a thorough understanding of the requirements for each CMC section of the Common Technical Document (CTD), i.e., the format to be used for NDAs. Additionally, the course will suggest ways to streamline the preparation of CMC documents, present techniques for making the CMC submission easy to review, and discuss how to address issues during CMC meetings with the FDA.