ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE
October 21 - 22, 2002
CDER Advisory Committee Conference Room
5630 Fishers Lane
Day 2: Tuesday, October 22, 2002
8:30 Call to Order Vincent H. L. Lee, Ph.D., Acting Chair
Conflict of Interest Kathleen Reedy Exec.Sec.
8:45 Future Subcommittee - GMP/Manufacturing
8:45 Introduction and Overview Ajaz Hussain, Ph.D. Deputy Director, OPS
9:00 Industry Perspective:
PhRMA Gerry Migliaccio
GPhA Stephen Bende, Ph.D.
9:30 Committee discussion
10:30 Manufacturing Issues: Sterile Drug Products Produced by Aseptic Processing
10:30 Introduction Ajaz Hussain, Ph.D.
10:35 Topic Introduction Joseph Famulare
11:00 Science Background and Issues Richard Friedman
11:40 Microbiology Review Perspective David Hussong, Ph.D.
1:00 Open Public Hearing
2:00 Manufacturing Issues cont.
(Break 3:00 - 3:15)
4:45 Conclusion and Summary Remarks Helen Winkle, Acting Director OPS