ADVISORY COMMITTEE FOR PHARMACEUTICAL S

Process Analytical Technologies Subcommittee of the

ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

Ramada Inn, Georgetown and Montrose Rooms, 1775 Rockville Pike, Rockville, MD

October 23, 2002

AGENDA

8:30 Call to Order Thomas Layloff, Ph.D., Acting Chair

Conflict of Interest Kathleen Reedy, Executive Secretary

8:40 Introduction to Meeting Ajaz Hussain, Ph.D. Deputy Director, OPS

9:00 Computer systems validation - Part 11 issues pertinent to PAT

Invited speakers: Guy Wingate, Ph.D.

Debbie Thomas

John Murray

10:30 Break

10:45 Computer systems validation - Part 11 issues pertinent to PAT cont.

Subcommittee Discussion

11:30 Open Public Hearing

12:30 Lunch

1:30 Breakout Sessions

A. PAT Mock Submission

B. Rapid Microbiology Testing

3:00 Break

3:45 Breakout Sessions Presentations to Subcommittee

PAT Mock Submission - 15 minutes

Rapid Microbiology Testing - 15 minutes

4:15 Subcommittee Discussion and Summary

4:50 Closing Remarks Ajaz Hussain, Ph.D.

5:00 Adjourn