Food and Drug Administration
October 21-22, 2003
Briefing Information
Introduction (HTM) (PDF) (Word)
Table of Contents (HTM) (PDF) (Word)
Guidance for Industry: PAT--A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance (PDF)
The Parametric Tolerance Interval Test (PTIT) - Background (HTM) (PDF) (Word)
Defining Quality of a Pharmaceutical Product, Dr. Janet Woodcock, MD, FDA (HTM) (PPT)
Quality by Design: Next Steps to Realize Opportunities?, Dr. Ajaz Hussain, PhD, FDA (HTM) (PPT)
FDA GMP Initiatives: Impact on CMC Reviews/Reviewers, Dr. Yuan-yuan Chiu, PhD, FDA (PDF)
Risk-Assessment Drug Product Quality Attributes, Dr. Vilayat Saueed, PhD, FDA (PDF)
Changes Without Prior Approval - An FDA Perspective, Dr. Dennis Bensley, Jr., FDA (HTM) (PPT)
A Perspective on Risk Analysis for the GMP Initiative, Dr. H. Claycamp, PhD, CHP, FDA (HTM) (PPT)
Changes Without Prior Approval, Rick Session, Aventis Pasteur, Inc. (HTM) (PPT)
Excerpt From the October 21, 2002 Transcript of the Advisory Committee for Pharmaceutical Science Meeting (PDF)
Update on Risk-Based CMC Review, Vilalyat Sayeed, PhD, FDA (HTM) (PPT)
Risk Based CMC Review - An Update, Dr. Yuan-yuan Chiu, PhD, FDA (HTM) (PPT)
Nomenclature - Issues and Challenges (HTM) (PDF) (Word)
Excerpt From the October 21, 2002 Transcript of the Advisory Committee for Pharmaceutical Science Meeting (PDF)
Research for Generics - Bioequivalence of Topical Products, Dr. Lawrence Yu, PhD (HTM) (PDF) (Word)