Food and Drug Administration

Pharmaceutical Science Advisory Committee

October 22, 2002

Slides

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

Comments to the Advisory Committee, G. Magliaccio (PDF) (Word)

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

FDA's Revision of the Aseptic Processing Guidance, Joseph Famulare, FDA (HTM) (PPT)

Preventing Contamination: Aseptic Processing Risk Factors, Richard Friedman, M.S.,  FDA (HTM) (PPT)

Regulatory Review of Sterile Drug Products' Applications, Dr. Hussong, FDA (HTM) (PPT)

FDA Preliminary Concept Paper Sterile Drug Products Produced by Aseptic Processing, Dr. Madson, FDA (HTM) (PPT)

Sterilization Options, Kristen Evans, FDA (HTM) (PPT)

Personnel Issues Addressed in Concept Paper, Robert Sausville, FDA (HTM) (PPT)

Environmental Control and Developing a Science-based Monitoring Program, Richard Friedman, M.S., FDA (HTM) (PPT)

Risk-Based Approach Process Simulation Media Fills, B. Uratani (HTM) (PPT)