Biomedical Engineering Reference
In-Depth Information
colleagues address software and web usability issues,
the principles of end-user and heuristic usability testing
apply to paper-based forms as well.
32. See Gerhard Becker (2007), for fi scal years 2005-2006,
and Gerhard Becker (2009), for fi scal years 2006-2008.
33. See ICH (2005), op. cit., p. 15.
34. See ICH (2005), ibid.
35. See FDA (2003).
36. See Duane Sylvia (2000). See the interview with Kristen
Evans, A CDER offi cial offers tips on inspections,
CDER Inspection Tips , Salt Lake City: Master Control
(2000), p. 4: “Training should not be a one-shot deal. It
has to be ongoing and dynamic.”
37. See James L. Vesper (2000), op. cit., p. 29.
38. John H. McConnell (2003).
7.8 References
Adriani, W., van der Tuuk, P.A., Smit, S. (2008) The pyramid
model as a structured way of quality management. Asian
J. Transfus. Sci. 2(1), 6-8.
Becker, G. (2007) Warning letters report 2006, GMP News ,
10 January.
Becker, G. (2009) Warning letters report 2008 - frequent
defi ciencies in deviation reviews, GMP News , 18 February.
Breggar, M. (2009) How to shift from reactive compliance to
strategic quality management. Bioph. Intern. 22(7), July.
Carnevale, A.P. et al. (1990) Training Partnerships: Linking
Employers and Providers , Report no. CE054867.
Alexandria, VA: ASTD.
Clark, R.C. (1994) Developing Technical Training , Phoenix:
Buzzards Bay Press.
Cochran, J.W., Nally, J.D. (2006) Organization and
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