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"A Drug Quality System for the 21st Century"

Breakout Session:
Risk-Based cGMPs: Defining Risk and Quality

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Table of Contents

A Drug Quality System for the 21st Century Breakout Session:
Risk-Based cGMPs: Defining Risk
and Quality

Definition of Risk

Points to Consider in Defining Risk

Definition of Quality in the Context of Mfg & Control of Products

Benefits of a Risk Based System

Benefits of a Risk Based System

Challenges

Challenges

Existing systems

Sector Specific Issues

Next Steps

Author: Edward Kaminski, PH.D., 
Wyeth Pharmaceuticals
April 24, 2003


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