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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 CMC course will allow you to arm yourself with the tools to write and/or assemble CMC sections of regulatory submissions, prepare for and orchestrate CMC meetings with the FDA, and provide a clear understanding on how to avoid noncompliance.
Course Level: Beginner/Intermediate

What you will learn

  • CMC components of investigational new drugs (INDs), new drug applications (NDAs), and Common Technical Documents (CTDs)
  • Tools to write or assemble CMC sections of regulatory submissions
  • How to prepare for CMC meetings with FDA
  • What FDA 483s are and how to avoid them
  • How to navigate through myriad guidelines and guidance documents

Who should attend?

  • Regulatory affairs professionals
  • Quality assurance and compliance personnel
  • Manufacturing personnel

Learning objectives

Participants who complete this training should be able to:

  • Recognize FDAs regulatory expectations and the regulatory framework
  • Outline the CM&C sections of INDs/NDAs/CTDs/DMFs
  • Assemble the CM&C sections of INDs and NDAs/CTDs
  • Address regulatory documents affected by CM&C
  • Design labels required for INDs and NDAs
  • Explain the FDA inspection process and how to avoid or minimize 483s
  • Construct a stability protocol