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Available at: fda. gov/ohrms/dockets/ac/06/slides/2006 4241s1 6. ppt accessed 9/7/2015. 13. ISPE PQLI. Draft PQLI summary update report. Org/cs/pqli product excellent lifeycle implementation /draft pqli summary Update report accessed 11/21/2007. 14. Food and Drug Administration: fda. gov/ohrms/ dockets/ac/06/minutes/2006–4228m1. pdf, 2006. 15. US Food and Drug Administration, Guidance for Industry: Q10 Pharmaceutical Quality Systems, 2009. 16. Guidance for industry “Q9 Quality Risk Management” by US branch of Health and Human Services, Food and drug Administration, Center for Drug and Evaluation Research, June 2006. 17. WHO Guideline on Quality Risk Management case answer draft advice August 2010. 18. Implementation of ICH Q9 in case analysis pharmaceutical field an example of methodology from PIC/S 2010. 19. Stephen Schneider, Professor of Biology and Global Change, Stanford University as revealed in Trashing case evaluation Planet by Dixie Lee Ray, p. 167. 20. Christine Stewart, former Canadian Minister of case analysis Environment, Calgary Herald, December 14, 1998. 21.
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