Food and Drug Administration

Adviosry Committee for Pharmaceutical Science

Manufacturing Subcommittee

July 21, 2004


FDA and Pharmaceutical Manufacturing Research Project, Jeffrey Macher and Jackson Nickerson, Georgetown University (HTM) (PPT)

Risk Ranking and Filtering and It's Role in Risk Management, H Claycamp, PhD, CHP, FDA (HTM) (PPT)

Pilot Risk-Ranking Model to Prioritize Manufacturing Sites for GMP Inspections, David Horowitz, Esq. (HTM) (PPT)

Details of FDA's Pilot Risk-Ranking Model for GMP Inspections, Dr. Nga Tran, Dr.PH and Brian Hasselbalch, FDA (HTM) (PPT)

Investigational New Drugs (INDs) Phase 1 - CMC Issues, Dr. Moheb Nasr, PhD, FDA (HTM) (PPT)

Draft Guidance for Industry: CGMPs for Phase 1 INDs, Joseph Famulare, FDA (HTM) (PPT)

Process Understanding and PAT, Dr. D. Watts, PhD, FDA (HTM) (PPT)

Comparability Protocol Update, Dr. Stephen Moore, PhD, FDA (HTM) (PPT)

Changes Without Prior Approval - How Do We Get There From Here? Jon Clark, FDA (HTM) (PPT)

Questions - Pilot Model for Prioritizing Site Selection for GMP Imspections (HTM) (PPT)