Food and Drug Administration

Adviosry Committee for Pharmaceutical Science

Manufacturing Subcommittee

July 20, 2004


Manufacturing Subcommittee, Dr. Ajaz Hussain, PhD, FDA (HTM) (PPT)

ICH Q8: Pharmaceutical Development, John Berridge, Pfizer Global R&D (HTM) (PPT)

Quality Risk Management, Frederick Razzaghi (HTM) (PPT)

Life Cycle Management for Process and System Control - An Industry Proposal, Dr. Tobias Massa, PhD (HTM) (PPT)

Standards for Pharmaceutical Applications of PAT, Don Marlowe (HTM) (PPT)

Reliability for the Analysis of Risk - A Bayesian Perspective, Nozer Singpurwalla (PDF)

Critical Path: The Industrialization Dimension, Dr. Ajaz Hussain, PhD, FDA (HTM) (PPT)

Pharmaceutical Manufacturing in the 21st Century: A "Science" Perspective, Dr. G Raju, PhD (HTM) (PPT)

Challenges and Opportunities in Enhancement of the CMC Section of NDAs: Quality - by - Design, Dr. Ajaz Hussain, PhD (HTM) (PPT)

Risk-Based CMC Review Paradigm, Dr. Moheb Nasr, PhD, FDA (HTM) (PPT)

Risk-Based CMC Review - OGD Perspective, Gary Buehler, RPh, FDA (HTM) (PPT)

Risk-Based Development and CMC Question-Based Review: Asking the Right Questions for Process Understanding, Control and Filing, Dr. Kenneth Morris, PhD, Purdue University (HTM) (PPT)

Questions - RiskBased CMC Review Paradigm (HTM) (PPT)