Biomedical Engineering Reference
In-Depth Information
reasonably be removed from consideration in an
investigation.
By contrast, it would be implausible to remove the trainer
and the training event from root cause consideration if the
trainer had been decreed “qualifi ed” by management through
the experiential approach.
7.3.3 Staffi ng considerations
It is most desirable that a qualifi ed trainer, who is also a SME
in the topic to be trained, is available to deliver the training.
What if such an individual is not available, either in-house or
externally? In that case, there seem to be three staffi ng
options that will meet regulatory requirements for cGMP
training to be delivered by “qualifi ed individuals.”
One option is to have a SME become qualifi ed as a trainer.
As Saundra Williams stresses, “Subject matter experts require
training in adult learning theory and training techniques
before they can adequately train others.” As a second point,
she notes, “Subject matter experts tend to know much more
information than they need to convey. This causes them to
overload the learner with information that is unrelated to job
needs.” Third, she continues, “Ineffective training delivery [by
SMEs] wastes dollars invested in instructors, training
materials, and employee time.” Finally, she points out that,
“SMEs who have not been given enough support in the
delivery of technical training may cause employees to feel
demoralized because they cannot apply the skills on the job.”
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A second option is to have a qualifi ed trainer become
profi cient as a SME on the topic to be trained. Linda Elengold
cautions, however, that, “it can take the generic trainer
weeks, if not months, to get up to speed on a specifi c process
or skill.” She concludes: “Many employers believe that it is
