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Navigating Chemistry, Manufacturing and Controls through the Drug Development Process


Overview

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 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.

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 CMC meeting with FDA
  • CMC and regulatory consideration with pediatric formulations
  • FDA 483s and how to avoid them
  • Navigation through the myriad guidelines and guidance documents

Who should attend?

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

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
  • Describe ways to construct a stability protocol