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 on-demand course has been assembled for the beginner in CMC as well as the intermediate professional who is looking for a refresher course in several facets of CMC. This course will review 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 the course is primarily focused on CDER and some CBER related products, some biologics and device CMC specific requirements will also addressed.

This on-demand training course takes an average of 12 hours to complete. Learners have access to the course for one year from the date of purchase.

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
- List the CMC sections of INDs/NDAs/CTDs/DMFs
- Define the CMC sections of INDs and NDAs/CTDs
- Identify regulatory documents affected by CMC
- Outline the FDA expectations regarding pediatric formulations
- Distinguish how to design labels required for INDs and NDAs
- Identify the FDA inspection process and how to avoid or minimize 483s and Warning Letters
- Determine ways to construct a stability protocol

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

Overview

What you will learn

Who should attend?

Learning objectives

Be informed and stay engaged.