Food and Drug Administration

Advisory Committee for Pharmaceutical Science

Manufacturing Subcommittee

September 17, 2003


Quality for the 21st Century Summary of FDA/PQRI Workshop, Dr. tobias Massa, PhD, Product Quality Research Institute (HTM) (PPT)

Defining Quality of a Pharmaceutical Product, Dr. Janet Woodcock, MD, FDA (HTM) (PPT)

Quality by Design: The Means To Fundamental Manufacturing Science, Dr. G. Raju, PhD (HTM) (PPT)

Assessing Quality-By-Design a CMC Review Perspective, Dr. Norman Schmuff, PhD (HTM) (PPT)

USing Manufacturing Science and Risk Management Principles to Achieve "Quality by Design," G. Migliaccio (HTM) (PPT)

Quality By Design - A Generic Industry Perspective, Edmund Fry, IVA Corp. (HTM) (PPT)

Risk-Based Development for Quality by Design, Ken Morris, Purdue University (HTM) (PPT)

Regulatory Assessment of Quality by Design, Joseph Famulare, FDA (HTM) (PPT)

Quality by Design: Next Steps to Realize Opportunities?, Dr. Ajaz Hussain, PhD, FDA (HTM) (PPT)

Designing Quality in, Colin Gardner, Transform Pharmaceuticals, Inc. (HTM) (PPT)

Use of Risk Management in Pharmaceutical Manufacturing (HTM) (PPT)

Open Public Hearing

Relationship Between Risk and application to Pharmaceuticals, Frederick Razzaghi, CHPA (HTM) (PPT)

Process Risk Assessment Model, Dr. Robert Menson, PhD, FDA (HTM) (PPT)