FDAs Advisory Committee for Pharmaceutical Science The Subcommittee on Process Analytical Technologies (PAT): Opening Remarks

6/14/02


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Table of Contents

FDAs Advisory Committee for Pharmaceutical Science The Subcommittee on Process Analytical Technologies (PAT): Opening Remarks

Goals and Objectives

Why PAT?

Strategy

Progress Report: Timeline

PAT Initiative:Timeline (2002)

Meeting #3

PAT Subcommittee Meeting #2: Day 1

PAT Subcommittee Meeting #2: Day 2

Questions for WG

Questions for WG

General (principles) Guidance on PAT

General principles and terminology

PPT Slide

A Historical Note on Quality: Lurching from Fad to Fad?

On/At-Line Assurance of Acceptable Dissolution Rate?

PPT Slide

PPT Slide

PPT Slide

PPT Slide

PPT Slide

Built-in Redundancy?

Author: CDER USER