Navigating Chemistry, Manufacturing and Controls through the Drug Development Process

Venue: DIA

Location: Horsham, Pennsylvania, United States

Event Date/Time: Sep 10, 2012 End Date/Time: Sep 11, 2012
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Description

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 course 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


Faculty
Albert S Yehaskel, MBA
Vice President, Regulatory Affairs
Refuah Global Pharmaceutical Development, Inc., United States


EVENT CODER:12436

Venue

DIA
Enterprise Drive Suite 200
Horsham
Pennsylvania
United States
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