Biomedical Engineering Reference
In-Depth Information
reinforcement training, re-training, Target Audience List,
training curriculum, Training Outline, training to a
procedure.
13.1 Introduction
The fi nal implementation of a training module comes among
the last phases of the program improvement model. A
performance gap or a training gap has been identifi ed in the
corrective action and preventive action (CAPA) plan as a
result of a revision of a standard operating procedure (SOP),
and a carefully planned approach to address the gap was
prepared. If management approves the design, the training
program, including training materials and assessment
materials, has been created in the development phase. These
training materials and assessment materials are rolled out in
a pilot implementation, a proof of concept study, highlighting
the iterative feature of the program improvement model. In
the case of a pilot implementation, the results of the program
evaluation are fed back, closing the loop, facilitating further
refi nement of the training program. In the evaluation phase
this is called a “formative evaluation.” Further design and
development efforts follow, until the module meets
organizational needs. Then comes the fi nal implementation
of the module.
In this age of technological change, much attention has
focused on the timing of training. On the one hand, training
is optimally delivered close enough to task performance to
ensure that the skill enhancement is still relevant but not yet
forgotten. These requirements have led to just-in-time
training (JITT), which has benefi ted from e-learning and
other developments.
1
However, in the pharmaceutical,
biopharmaceutical, medical device, blood product, and other
