Biomedical Engineering Reference
In-Depth Information
How do we align the procedure and its associated training?
How do we provide the supervisor with necessary information
about changes to relevant procedures so as to ensure that
employee training and qualifi cation are completed and
documented?
13.4.3 The role of the training outline
As discussed in Chapter 5, a Training Outline is a controlled
document that provides a brief summary of the training
implications of a new or revised procedure. The Training
Outline allows any employee to quickly ascertain critical
dimensions of training associated with a particular SOP,
including the behavioral objectives of the training, the
training module's fi t in the larger curriculum, the delivery
method, assessment materials, and of course the training
audience.
When a performance gap or training gap is identifi ed,
management must decide on the appropriate CAPA to
respond to the gap. There are two possibilities:
1. it involves a life-cycle document or documents; or
2. it involves non-life-cycle or GMP regulatory training.
In either case, the associated training will require the
development or revision of a Training Outline. The
instructional designer (or originator of the procedure)
will ask “Does a Training Outline exist?” If one already
exists, the Training Outline will be reviewed and revised
as necessary. If not, one will be prepared.
The instructional designer will review fi ve points:
1. Does the SOP or other document contain background
history or perspective of the process that would aid in
the training?
