The Center for Professional Innovation & Education, Malvern, PA
Who Should Attend
This course is designed for personnel involved in preparing the chemistry, manufacturing and controls (CMC) section of a NDA or IND in CTD format. Note that the course does not cover a BLA, which is for biologics. However, 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 will also benefit from the course.
This course provides participants with 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.
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 an outline of what is required in the drug substance and drug product sections of INDs. The course emphasizes the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities and stability, and pharmaceutical development reports. It will also discuss the use of Drug Master Files (DMF) and comparability protocols.