Biomedical Engineering Reference
In-Depth Information
18. Available from:
www.fda.gov/ora/frequent/letters/
ARC_20060727_ADLetter.pdf
19. This is obvious for skill training; as Michael Swartz and
Ira Krull (2004), esp. p. 906, have expressed it for
training in cGMP regulations: “It is of little value to
train or educate an employee on all of the regulations if
there is no impact on the job that person fulfi lls every
day.”
20. Available from:
www.fda.gov/foi/warning_letters/
archive/g4683d.pdf
21. See John DiLollo (2000).
22. As Katherine Beauchemin
et al.
(2001), esp. p. 11, have
accurately put it, “Clearly the 'read and understand'
method does not meet the criteria set out for validity
and reliability;” see also Bringslimark (2004), op. cit.,
p 46.
23. See James Vesper (2000), esp. p. 29.
13.7 References
Beauchemin, K.
et al
. (2001) 'Read and understand' vs 'a
competency-based approach' to designing, evaluating,
and validating SOP training.
PDA J. Pharma. Sci. Tech.
55(1), 10-15.
Bohte, J., Meier, K. (2000) Goal displacement: assessing the
motivation for organizational cheating.
Publ. Admin. Rev.
60(2), 173-82.
Bringslimark, V. (2004) If training is so easy, why isn't
everyone in compliance?
Biopharm Intern.
17(1), 46-53.
DiLollo, J. (2000) The use of SOPs in a pharmaceutical
manufacturing environment.
J. cGMP Comp
. 4(3), 33-5.
Fuller, N. (2006) FDA Fines City Red Cross in Training
Irregularity,
Baltimore
Sun
, 2 August.
