Biomedical Engineering Reference
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training unit as its audience; the second and third modules
have the prospective qualifi ed trainers as their audience.
Document-based training and non-document-based
training must carefully be distinguished in the Design phase;
if not, there is the possibility that all the training modules in
non-document-based training will be named after the same
procedure. We have seen instances where a several-hour
classroom session of mandated training had the same name
and course number as a one-hour program management
course, causing confusion in the training tracking system and
among the several training audiences.
It is better to delineate clearly the more complex relationship
between training modules and the associated procedure.
Figure 5.5 more clearly displays the non-document-based
training structure; it is now viewed as similar to a GMP
regulatory procedure, where there is training to the procedure
and also (a different thing) training on courseware that is
mandated by the procedure.
￿ ￿ ￿ ￿ ￿
Figure 5.5
Non-document-based training modules
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