Biomedical Engineering Reference
In-Depth Information
7.3.2 Approaches to trainer qualifi cation
There are two basic approaches to qualifying cGMP trainers.
One is a
formal
approach, such as a TTT program; the other
is an
experiential
approach, based on management's
judgment that an employee is qualifi ed to provide training.
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A GMP TTT program provides a formalized approach to
the selection of candidates for the training, the delivery of
the classroom session, the aspiring trainer's preparation and
delivery of a presentation to demonstrate profi ciency, and
the assessment of the aspiring trainer's performance.
In the case of the experiential approach to the qualifi cation
of trainers, management selects the “qualifi ed trainer” based
on more or (usually) less explicit criteria and documentation.
This approach to trainer qualifi cation is less demanding than
the formal approach, including less demand on resources.
The formal approach to the qualifi cation of trainers has
several advantages over the experiential approach.
Importantly, it tends to homogenize the delivery of training
events. This tends to reduce the variation in subsequent
performance across trainees (employees).
Human error - Reason's “active failure” - is frequently cited
as the root cause of deviations in investigations.
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The deviation
is frequently attributed to a training inadequacy on the part of
the employee whose performance has failed, causing the
deviation. This training inadequacy, in turn, is attributed to an
inadequacy of the trainee, the training event, or the trainer, in
some combination. However, if three conditions are met:
1. the trainer has been rigorously qualifi ed in terms of the
formal approach;
2. the qualifi cation has been periodically monitored; and
3. tracking and trending of other deviations does not show
recurrences, then the trainer and the training event can
