Utilizing Chemistry, Manufacturing & Control (CMC) in Drug Development

Date(s) And Time(s):
Oct 7 2010 8:30AM - Oct 8 2010 4:30PM

Location:
Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509

Interest Area(s):
CMC, Regulatory Affairs

Overview:

Navigate the CMC Compliance Maze

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:
10413

Contact Information:

For detailed program information including faculty and topics, please contact:
Susan Mazak
Tel. +1-215-442-6183
Email Susan.Mazak@diahome.org

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