Food and Drug Administration

Center for Drug Evaluation and Research


Manufacturing Subcommittee

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



  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



3:15    Break


3:30    Subcommittee next steps                                                Helen Winkle


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


4:30    Adjourn