Process Analytical Technologies Subcommittee of the
Advisory Committee for Pharmaceutical Science
February 25 - 26, 2002
Holiday Inn, 2 Montgomery Village Avenue
Gaithersburg, MD
AGENDA
Day 1: Monday, February 25, 2002
8:30 Call to Order Thomas Layloff, Ph.D., Acting Chair
Conflict of Interest Nancy Chamberlin, Pharm.D., Exec.Sec.
8:45 Introduction, Overview, and Ajaz Hussain, Ph.D., Deputy Director,
Objectives for Subcommittee Office of Pharmaceutical Science
Process Analytical Technologies Applications and Benefits
9:15 Perspective 1 Steve Hammond, Pfizer
9:35 Perspective 2 Doug Dean, Ph.D., PricewaterhouseCoopers
9:55 Subcommittee Discussion
10:30 Break
Product and Process Development
10:45 Perspective 1 John G. Shabushnig, Ph.D., Pharmacia
11:05 Perspective 2 David R. Rudd, Ph.D., GlaxoSmithKline
11:25 Subcommittee Discussion
12:00 Lunch
1:00 Open Public Hearing
Process and Analytical Validation
2:00 Perspective 1 Robert S. Chisholm, AstraZeneca
2:20 Perspective 2 Leon Lachman, Ph.D., Lachman Consulting
Day 1 (continued): Monday, February 25, 2002
2:40 Subcommittee Discussion
3:10 Break
Chemometrics
3:25 Perspective 1 Jerry Workman, Jr., Ph.D., Kimberly-Clark
3:45 Perspective 2 Dwight S. Walker, Ph.D., GlaxoSmithKline
4:05 Subcommittee Discussion
5:30 Adjourn
Process Analytical Technologies Subcommittee of the
Advisory Committee for Pharmaceutical Science
February 25 - 26, 2002
Holiday Inn, 2 Montgomery Village Avenue
Gaithersburg, MD
AGENDA
Day 2: Tuesday, February 26, 2002
8:00 Call to Order Thomas Layloff, Ph.D., Acting Chair
8:15 Charge to Working Groups Thomas Layloff, Ph.D., Acting Chair
8:30 Working Group Discussions (four separate groups)
10:30 Break
10:45 Working Group Discussions
12:00 Lunch
1:30 Open Public Hearing
Working Group Summaries (joint)
2:00 PAT Applications and Benefits Arthur Kibbe, Ph.D., Acting WG Chair
2:15 Subcommittee Questions and Answers
2:30 Product and Process Development Judy Boehlert, Ph.D, Acting WG Chair
2:45 Subcommittee Questions and Answers
3:00 Break
3:15 Process and Analytical Validation Leon Lachman, Ph.D , Acting WG Chair
3:30 Subcommittee Questions and Answers
3:45 Chemometrics Melvin Koch, Ph.D., Acting WG Chair
4:00 Subcommittee Questions and Answers
Day 2 (continued): Tuesday, February 26, 2002
4:15 Subcommittee Discussion
4:45 Summary Ajaz Hussain, Ph.D., Deputy Director,
Office of Pharmaceutical Science
4:55 Closing Remarks Thomas Layloff, Ph.D., Acting Chair
5:00 Adjourn