About FDA
Selected Publications
FDA 2011 Process Validation Guidance: Process Validation Revisited
By Paula Katz and Cliff Campbell
FDA 2011 Process Validation Guidance: Process Validation Revisited (PDF - 436KB)
Journal of GXP Compliance (Autumn 2012)
With permission from IVT 
PQRI-FDA Summary on Process Drift: Detection Measurement and Control in Pharma Manufacturing
By Margaret M. Szymczak, Richard L. Friedman, Rajendra Uppoor, and Avraham Yacobi
PQRI-FDA Summary on Process Drift (PDF - 4KB)
Pharmaceutical Technology (Oct 2011)
With permission from PharmTech
Burkholderia cepacia: This Decision Is Overdue
Lynn Torbeck, Diane Raccasi, Dennis E. Guilfoyle, Richard L. Friedman, and David Hussong
PDA J Pharm Sci Technol (Sep/Oct 2011);65 535-543
Burkholderia cepacia: This Decision Is Overdue (PDF – 285KB)
With permission from PDA
Protecting the Public’s Health Through the Application Integrity Policy
Protecting the Public’s Health Through the Application Integrity Policy (PDF - 430KB)
Food and Drug Law Journal
Volume 65, Issue 3 (2010)
With permission from FDLI
Process Robustness - A PQRI White Paper
Pharmaceutical Engineering (Nov/Dec 2006, Vol. 26 No. 6)
With permission from PQRI
Elicitation of Expert Knowledge about Risks Associated with Pharmaceutical Manufacturing Processes
Pharmaceutical Engineering (Jul/Aug 2005, Vol. 25 No. 4)
With Permission from ISPE
Aseptic Processing Contamination Case Studies and the Pharmaceutical Quality System
With permission from PDA
