Arm yourself with the tools to write or assemble CMC sections of regulatory submission, to prepare for CMC meetings with FDA, and to avoid non-compliance.

WHAT YOU WILL LEARN
• FDA's regulatory expectations and the regulatory framework
• Structure of CMC sections of INDs/NDAs/CTDs/DMFs
• Regulatory documents affected by CMC
• Labels required for INDs and NDAs
• How to comprehend and construct a stability protocol



Learning Objectives:
At the conclusion of this course, participants should be able to:
• Recognize FDAs regulatory expectations and the regulatory framework
• Understand the structure of CMC sections of INDs/NDAs/CTDs/DMFs
• Be able to assemble the CMC sections of INDs and NDAs/CTDs
• Address regulatory documents affected by CMC
• Have a deep understanding and knowledge of the appropriate resources available to them
• Design labels required for INDs and NDAs
• Know the FDA inspection process and how to avoid or minimize 483s
• Comprehend and construct a stability protocol

Target Audience:
• Regulatory affairs professionals
• Quality assurance and compliance personnel
• Manufacturing personnel

Event Code:
11432