Food and Drug Administration
Process Analytical Technologies Subcommittee of the Advisory Committee for Pharmaceutical Science
June 12, 2002
Slides
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