Manufacturing Subcommittee

September 17, 2003

CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD




Agenda: September 17, 2003


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

            Conflict of Interest                                           Hilda Scharen, Exec. Sec.


8:45     Introduction to Meeting                                Ajaz Hussain, Ph.D., Deputy Director OPS


9:00     PQRI/FDA Workshop Report Summary          Tobias Massa, Ph.D.


9:15     Defining Quality                                               Janet Woodcock, MD, Director CDER


9:30     Considerations for "Quality by Design"           G K Raju, Ph.D.


10:00   Current Regulatory Challenges in

Assessing "Quality by Design"                        Norman Schmuff, Ph.D.


10:30   Break

10:45   Proposals for Regulatory Assessment of "Quality by Design"

            Industry           - PhRMA                                              Gerry Migliaccio

                                    - GPhA                                    Gordon Johnston

            Academic                                                                     Kenneth Morris, Ph.D.

Regulatory       - GMP                                                  Joe Famulare

                        - CMC                                                  Ajaz Hussain, Ph.D.


11:45   Open Public Hearing


12:45   Lunch


1:45     Committee Discussion and Recommendations                      


2:45     Break


3:00     Quality by Design and Risk Based Regulatory Scrutiny

            CMC: Specifications and Post-Approval Changes      Colin Gardner, Ph.D.

            GMP:                                                                           Greg Guyer, Ph.D.


4:00     Committee Discussion and Recommendations


4:45     Closing Remarks                                                         Ajaz Hussain, Ph.D.


5:00     Adjourn