Food and Drug Administration
Process Analytical Subcommittee of the Pharmaceutical Science Advisory Committee
October 23, 2002
Briefing Information
Memorandum to the Committee Members and Discussants, Dr. Ajaz Hussain, PhD, FDA HTM PDF Word
Process Analytical Technology Initiative Rapid Microbiology Methods HTM PDF Word
General Principles of Software Validation; Final Guidance for Industry and FDA Staff PDF
Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices PDF
Guidance for Industry Computerized Systems Used in Clinical Trials PDF
Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Glossary of Terms PDF
Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Validation PDF
Computerized Devices/Processes Guidance - Application of the Medical Device GMP to Computerized Devices and Manufacturing Processes, Medical Device GMP Guidance for FDA Investigators, May 1992 PDF
Validation Perceptions That May Slow PAT Development and Implementation, Steve Hammond, Pfizer Global Manufacturing HTM Ppt
Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach PDF Word