Second Meeting of the FDA/ACPS Process Analytical Technology: Closing Remarks

6/14/02


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Table of Contents

Second Meeting of the FDA/ACPS Process Analytical Technology: Closing Remarks

A Reminder

Process Understanding

Limited, but sufficient for approval, process understanding can lead to …..

Approaches for minimizing “risks”

Current System

PAT System

Emerging PAT Guiding Principles

Emerging PAT Guiding Principles

Emerging PAT Guiding Principles

Is Industry willing to move?

Meeting #3 (one day meeting)

Author: CDER USER