Biomedical Engineering Reference
In-Depth Information
approval, the Target Audience List will be circulated as well.
Management of each unit impacted by the procedure will
review the list and recommend limiting it or expanding it,
based on their direct responsibility for the task assignments
of the listed employees.
The instructional designer will then take those
recommendations into account as the procedure, Training
Outline, and Target Audience List are reviewed and approved.
Moreover, management in the impacted units are alerted for
the approval and implementation dates of the SOP, and can
accordingly schedule personnel for necessary training on the
fi nalized module.
After the new or revised SOP has been approved, there is a
“training window” before the procedure goes into effect, a
time period within which the impacted employees can be
trained to the SOP. This window is typically a week or two
in length. It is critical that the training audience be defi ned
before that window opens, hence before the SOP is approved,
so that all training on the fi nalized module will be completed
before the implementation date.
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Thus, the risk of untrained
personnel touching the regulated product will be minimized.
13.5 Conclusion
This chapter had three parts. We fi rst reviewed the scope and
impact of the FDA regulations of pharmaceutical
manufacturing in general, and of training in particular, and
found them to be comprehensive. Any person who touches
the regulated product, or who supervises that person, falls
within the scope of the regulations. These regulations impact
on these persons via written SOPs that provide comprehensive
guidance for drug manufacturing. These persons must be
trained on these procedures insofar as they relate to the
