Biomedical Engineering Reference
In-Depth Information
5. For biopharm personnel, 21 CFR 600.10; for non-
clinical lab personnel, 21 CFR 58.29; for medical device
personnel, 21 CFR 820.25; for human tissue recovery
personnel, 21 CFR 1271.170.
6. Available from:
www.fda.gov/foi/warning.htm
7. Cited in “Production Procedure, QC Unit Citations Top
FDA-483 List,”
Gold Sheet
, Vol. 38, No. 5 (2004),
pp. 3-4. For FDA inspections conducted from 2001 to
2003, inadequacy of training was the seventh most cited
observation, with 173 observations out of a total of
1933.
8. See the FDA Warning Letter dated 24 June 2005 to
Greer Laboratories, Inc. Available from:
www.fda.gov/
foi/warning_letters/archive/g5395d.pdf
9. See John Levchuk (1990).
10. See David Gallup
et al.
(2003), esp. pp. 49-50 for an
insightful discussion of FDA requirements for training
documentation; also Vivian Bringslimark (2004), esp.
pp. 51-52.
11. See James Vesper (2001), esp. p. 44.
12. Available from:
www.fda.gov/ora/frequent/letters/
ARC_20060727_ADLetter.pdf
. See also Nicole Fuller
(2006).
13. See Robert Merton (1957); also John Bohte and Kenneth
Meier (2000).
14. See Philip Lindemann (2006).
15. As Levchuk, op. cit. has commented, however, “usually,
available information is inadequate to establish a
specifi c reason beyond failure to have a training
program, failure to follow the written training
program, or failure to ensure that personnel received
training.”
16. See Levchuk, op. cit.
17. See also Vesper (2001), op. cit., p. 46.
