Food and Drug Administration

Advisory Committee for Pharmaceutical Science

Manufacturing Subcommittee

May 21, 2003


Welcome, Dr. Winkle, FDA (HTM) (PPT)

FDA's Perspective Continued - Where We Are? Dr. Winkle, FDA (HTM) (PPT)

FDA's Perspective on the "Pharmaceutical cGMPs for the 21st Century" Initiative, David Horowitz, Esq. (HTM) (PPT)

Manufacturing Science: The Means to GMPs in the 21st Century, Dr. G. Raju, PhD (HTM) (PPT)

Generic Industry's Perspective on the New GMP Initiative, Kenneth Lavin, M Sc., TEVA Pharmaceuticals USA (HTM) (PPT)

Drug Quality Regulations for the 21st Century, PhRMA Perspective, Gerry Migliaccio, Pfizer, Inc. (HTM) (PPT)

Identification and Prioritization of Topics for Discussion, Dr. Ajaz Hussain, PhD, FDA (HTM) (PPT)

Open Public Hearing

Creating Your Own SUPAC, Colin Gardner, Transform Pharmaceuticals, Inc. (HTM) (PPT)

MCC Position Regarding PAT, Dr. Frederick Razzaghi, MCC of CHPA (PDF)