Biomedical Engineering Reference
In-Depth Information
L. Pedigo (2005); also see Christopher Smalley (2008)
for further discussion of KTAs.
9. See, for example, Andrew Budson and Bruce Price
(2005). They point out that the inferolateral temporal
lobes are critical for the semantic memory system, the
medial temporal lobes, including the hippocampus and
parahippocampus, form the core of the episodic memory
system, while the basal ganglia, cerebellum, and
supplementary motor area are critical for procedural
memory.
10. See Gerald McDonnell (2007); also see International
Organization for Standardization (2000).
11. See Steven Ostrove (2008).
12. See Bohdan Ferenc (1999).
13. See FDA (2008)
Guidance for Industry, Process
Validation:
General
Principles
and
Practices
,
“Performance Qualifi cation Approach.”
14. As Christopher Smalley (2008) has put it:
How does a new employee become educated in the
skills needed to perform their job safely and
effectively? Imagine for a moment that we are
performing an IQ similar to that for a new piece of
equipment. Are your specifi cations adequate? That
is, are the job description and other documentation
that describe the job to be performed adequate?
What are the minimum requirements for the
employee being 'installed'? op. cit., p. 519.
15. On the closely related notion of trainability testing, see
Dominic Cooper
et al
. (2003); also Sylvia Downs (1985).
16. In a non-GMP framework, say OSHA, the performances
are related elsewhere - say to the industrial safety of the
employee.
