Biomedical Engineering Reference
In-Depth Information
4. See FDA,
Pharmaceutical cGMPs for the 21st Century
- A Risk-Based Approach, Final Report-Fall 2004
,
September 2004. See also John Gardner's comments, as
reported in Joseph Pickett, “GMP audit imminent after
6-year inspection gap, states 2007 risk-based model:
Gardner,”
Validation Times
, September 2007.
5. See International Conference on Harmonisation
(ICH) (2005).
6. ICH,
Q9, Quality Risk Management
, op. cit., p. 2.
7. 21 CFR 211.25(a), Personnel qualifi cations.
8. 21 CFR 606.20, Personnel. The relevant phrase is
“adequate information concerning the application
of pertinent provisions of this part to their respective
functions.”
9. See European Union (2009) ∫2.9. Health Canada (2009),
Regulation C.02.006. ∫ 6.
10. See FDA (2006). Thus a business rationale as well as a
compliance rationale can be made for continuing
training. For the business rationale, see Anne Garstka
and Donald E. Hagman (2000), “training must be
continuous. By providing continuous training,
pharmaceutical companies instill good habits that lead
to safe, effective products and higher profi ts.”
11. International Conference on Harmonisation (2001),
∫3.12. [Published in the Federal Register, Vol. 66, No
186, 25 September 2001, pp. 49028-49029.]
12. Regarding clinical trials staff, see Barry Strack (2005),
“the incorporation of continued training is an important
element that many popular programs neglect to focus
on.” See also Akanksha Saxena (2005), “management
should see to it that there is continuous training of SOPs
among the staff.” Also US Department of Veterans
Affairs (2003), VHA Directive 2003-036, requires
“appropriate training in the ethical principles and good
