The Center for Professional Innovation & Education, Costa Mesa, CA
March 15 & 16, 2010
Who Should Attend
This course is designed for personnel involved in preparing the chemistry, manufacturing and controls (CMC) section of a NDA or IND and for personnel who are not involved in CMC document preparation but want an overall understanding of what is involved for both the drug substance and drug product.
Note that the course covers the requirements for synthetic, small molecules and does not address biologics.
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.
This course includes an overview of the International Conference on Harmonization (ICH) process and the organization of the CTD, detailed information and discussions related to each element required in the drug substance and drug product sections of NDAs and INDs. The course will emphasize the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, and pharmaceutical development reports. It will also discuss the use of Drug Master Files (DMF) and preparation of the CTD Quality Overall Summary (Module 2).