Food and Drug Administration

Process Analytical Technologies Subcommittee of the Advisory Committee for Pharmaceutical Science

June 12, 2002


Opening Remarks, Dr. Ajaz Hussain, PhD, FDA  htm  ppt

Regulatory Challenges: PAT Applications in NDAs, Dr. Jeffrey Blumenstein, PhD, Pfizer, Inc.  htm  ppt

Regulatory Challenges: Post-Approval PAT Applications, Dr. Dhiren Shah, PhD, Aventis Pharmaceuticals  htm  ppt

Development/Compliance Issues, Hank Avallone, Pharmaceutical Sourcing Group Americas  ppt

Chemical Science and Technology Laboratory Overview, James Whetstone  ppt

Process and Analytical Validation Working Group, Dr. Arthur Kibbe, PhD  htm  ppt

PAT Product-Process-Development Work Group  htm  doc  pdf

Proposed PAT Certification Program for FDA Investigators and Reviewers  htm  doc  pdf

Summary and Closing Remarks, Dr. Ajaz Hussain, PhD, FDA  htm  ppt