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Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process


The regulations surrounding Chemistry, Manufacturing, and Controls (CMC) can often seem daunting and challenging. However, with the proper training and knowing where to look amongst the FDA regulations and other important resources, you can become an informed and knowledgeable regulator that can tackle CMC issues. This course has been assembled for the beginner in CMC as well as the intermediate CMC professional who is looking for a refresher course in several facets of CMC. This interactive course will allow you to apply several of the principals learned to real-life situations and to arm yourself with the tools to write and/or assemble CMC sections of regulatory submissions (INDs, NDAs, DMFs, ANDAs, etc.), prepare for and orchestrate CMC meetings with the FDA, and provide a clear understanding on how to avoid noncompliance. While this course is focused on CDER and some CBER related products, the instructor will endeavor to address biologics and device questions during the progression of this course. Finally, the course will offer interactive and collaborative workshops.

What you will learn

  • The CMC components of INDs and NDAs/CTDs
  • Tools to write or assemble CMC sections of regulatory submissions
  • How to prepare for a successful and productive CMC meeting with FDA
  • CMC and regulatory consideration with pediatric formulations
  • FDA 483s, Warning Letters and how to avoid them
  • Preparing for a PAI
  • Navigation through the myriad guidelines and guidance documents

Who should attend?

  • Regulatory affairs professionals
  • Quality assurance and compliance personnel
  • CMC and manufacturing personnel
  • CMOs, clinical supplies personnel, and those involved in drug development requiring some CMC background
  • IP professionals who would like to obtain a better understanding of the CMC processes
  • Document management personnel who assemble CMC sections and would like to have a clear understanding of CMC and the eCTD modules

Learning objectives

At the conclusion of this course, participants should be able to:

  • Recognize FDAs regulatory expectations and the regulatory framework
  • Outline the CMC sections of INDs/NDAs/CTDs/DMFs
  • Assemble the CMC sections of INDs and NDAs/CTDs
  • Address regulatory documents affected by CMC
  • Discuss the FDA expectations regarding pediatric formulations
  • State how to design labels required for INDs and NDAs
  • Explain the FDA inspection process and how to avoid or minimize 483s and Warning Letters
  • Discuss ways to construct a stability protocol

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