Biomedical Engineering Reference
In-Depth Information
FDA (2004) Pharmaceutical cGMPs for the 21st Century -
A Risk Based Approach, Final Report - Fall 2004 ,
September.
FDA (2006) Guidance for Industry: Q9 Quality Risk
Management , Rockville, MD: CDER, June, p. 13.
FDA (2006) Guidance for Industry: Quality Systems
Approach to Pharmaceutical cGMP Regulations ,
Rockville, MD: CDER, September, p. 13.
Garstka, A., Hagman, D.E. (2000) The benefi ts of training
right. SP Forum , 9 March.
Health Canada (2009) Good Manufacturing Practices
(GMP) Guidelines - 2009 Edition (GUI-0001) , Ottawa:
Health Canada.
Hubby, S.A. (2009) Integration of Q9 quality risk
management when conducting GCP regulatory inspections
and audits, presented at the 45th Annual Meeting, Drug
Information Association (DIA) , San Diego, CA.
International Conference on Harmonisation (ICH) (2001)
Good Manufacturing Practice Guide for Active
Pharmaceutical Ingredients - Q7A , Geneva: ICH Secretariat.
International Conference on Harmonisation (ICH) (2005)
Quality Risk Management Q9 , Geneva: ICH Secretariat,
9 November, pp. 2-4.
McConnell, J.H. (2003) How to Identify Your Organization's
Training Needs , New York: AMA, p. 108.
Nielsen, J. (1994) Usability Inspection Methods, CHI'94
Companion, Association for Computing Machinery ,
Boston, MA, 24-28 April, pp. 413-14.
Nielsen, J., Molich, R. (1990) Heuristic evaluation of user
interfaces. CHI'90 Conference, Proceedings of the
Association for Computing Machinery , Seattle, WA, 1-5
April, pp. 249-56.
Nielsen, J., Pernice Coyne, K., Tahir, M. (2001) Make it
usable. PC Mag. 20(3), 6 February.
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