Food and Drug Administration
Manufacturing Subcommittee
July 20, 2004
Slides
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)