Overview

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 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
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

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

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