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. 



Learning Objectives

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.



Course Description

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).



View Course Agenda



Past Participant's Comments:

“This course was very informative and helpful in understanding and interpreting the requirements needed for NDAs and INDs.  The instructor was extremely knowledgeable.” 
Elicia H., Sr. Doc. Control Specialist, CIMA Labs

“This CMC course was a great overview for my current job.  I will be able to use everything I learned right away.  This has not been the case for other courses I have taken.  Thanks!” 
Shawna W., Scientist-CMC Writing, Celgene

“The Course Director is a very professional presenter and knowledgeable.  You can see how much experience she has and that makes the course very interesting.  She keeps the students engaged and attentive.”
Liliana A., Manager-Regulatory Affairs Int’l., GE Healthcare

“An excellent seminar for everyone coordinating, writing or reviewing the CMC sections of drug substance and drug product NDAs/INDs for small molecules.” 
A. Agidotan, Manager, PharmaLex GmbH

“Very comprehensive but concise.  I’d highly recommend to anyone who is involved in writing the CMC section at whatever skill level they may be at.” 
Ruby R., Stability Specialist, Amgen

“Great course!  The course director was very knowledgeable and an excellent communicator.”
Mary H., Research Associate,  Merck