Food and Drug Administration

Center for Drug Evaluation and Research

ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

Manufacturing Subcommittee

CDER Advisory Committee Conference Room, 5630 Fishers Lane, Rockville, MD

Agenda

March 21, 2003

8:30: Call to Order and Introductions: Judy P. Boehlert, Ph.D., Chair air

Meeting Statement: Kathleen Reedy, Executive Secretary

8:15 Introduction to Meeting Helen Winkle, Acting Director OPS

8:45 Purpose and mission of the subcommittee

9:15 Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach

Introduction Helen Winkle

David Horowitz

10:30 Break

10:45 Pharmaceutical cGMPs for the 21st Century cont.

GPhA Perspective Ken Lavin, TEVAUSA

PhRMA Perspective Gerry Migliaccio, Pfizer

Committee Discussion

11:30 Open Public Hearing

12:30 Lunch

1:30 Update - ACPS Process Analytical Technologies Ajaz Hussain, Ph.D.

(PAT) Subcommittee

2:30 Update - Regulatory approaches regarding

aseptic manufacturing

Issues and future plans Joseph Famulare

Richard Friedman

PQRI Aspect Glen Wright, Lilly

Conclusions

3:15 Break

3:30 Subcommittee next steps Helen Winkle

4:00 Conclusions and Summary Remarks Ajaz Hussain, Ph.D.

4:30 Adjourn