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Navigating Chemistry, Manufacturing and Controls through the Drug Development Process

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Overview 

Participants in this course will learn how to write and assemble the Chemistry, Manufacturing and Control (CMC) sections of regulatory submissions. Learners will also be prepared for CMC meetings with the US Food and Drug Administration (FDA) and be taught how to avoid noncompliance.

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

Contact Information 

Jessica McGrory at +1-215-442-6182 or Jessica.McGrory@diahome.org

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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