Food and Drug Administration

Process Analytical Technologies Subcommittee of the Advisory Committee for Pharmaceutical Science

June 12, 2002


Proposed PAT Curriculum for FDA Inspectors and Reviewers doc  htm  pdf

 Application and Benefits Work Group  ppt  htm

Product and Processing Work Group  ppt  htm  pdf

Process and Analytical Validation Work Group  ppt  htm  pdf

Chemometric Work Group  ppt  htm  pdf

Process and Validation Work Group Transcript  doc  htm

Quality by Design: A Challenge to the Pharma Industry, Camp  ppt  htm  pdf

FDA Regulation of Drug Quality: New Challenges, Dr. Janet Woodcock, MD, FDA  ppt  htm  pdf

The PAT Initiative: Progress Report and Next Step, Dr. Ajaz Hussain, PhD ppt  htm  pdf