Food and Drug Administration
Center for Drug Evaluation and Research
ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE
Committee Conference Room,
: Call to Order and Introductions: Judy P. Boehlert, Ph.D., Chair air
Meeting Statement: Kathleen Reedy, Executive Secretary
Introduction to Meeting Helen Winkle, Acting Director OPS
Purpose and mission of the subcommittee
Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach
Introduction Helen Winkle
Pharmaceutical cGMPs for the 21st Century cont.
GPhA Perspective Ken Lavin, TEVAUSA
PhRMA Perspective Gerry Migliaccio, Pfizer
Open Public Hearing
Update - ACPS Process Analytical Technologies Ajaz Hussain, Ph.D.
Update - Regulatory approaches regarding
Issues and future plans Joseph Famulare
PQRI Aspect Glen Wright, Lilly
Subcommittee next steps Helen Winkle
Conclusions and Summary Remarks Ajaz Hussain, Ph.D.