ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

October 21 - 22, 2002

CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD

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

10:15 Break

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.

12:00 Lunch

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

5:00 Adjourn