Food and Drug Administration

Advisory Committee for Pharmaceutical Science

Manufacturing Subcommittee

May 22, 2003


PAT Initiative: Next Steps, Dr. Ajaz Hussain, PhD, FDA (HTM) (PPT)

Changes Without Prior Approval, An FDA Perspective, Dr. Dennis Bensley, PhD, FDA (HTM) (PPT)

A Perspective on Risk Analysis for the GMP Initiative, Dr. H Claycamp, PhD, FDA (HTM) (PPT)

Synopsis of 1987 Aseptic Processing Guidance Revision, Drs. Famulare, Friedman, & Wright (HTM) (PPT)

Next Steps (Topics for the Next Meeting), Dr. Ajaz Hussain, PhD, FDA (HTM) (PPT)