Biomedical Engineering Reference
In-Depth Information
Warning Letter to Pharmaceutical Formulations, Inc. dated
5 May 2004: “Process failures resulting in the rejection of
substantial quantities of drug products were not investigated
and there is no documentation to show any corrective
actions.”
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Returning to the fi rst problem, it is crucial to recognize the
misspecifi cation of task responsibilities in the proposed Task
Assignment Procedure. This procedure places the key
responsibility on the supervisor for ensuring that employee
training and qualifi cation requirements are completed and
documented, while not giving that supervisor necessary
information about the accuracy and currency of the curricula,
the status of procedure initiation, the status of procedure
revision.
Instead, the Task Assignment Procedure should ensure
that the originator (or business owner) of any new or revised
SOP communicates with each impacted functional area to
determine who the impacted employees are, that is, the
training audience for the forthcoming SOP. This brings us to
the third part of this chapter, where we propose an alternative
approach to ensuring that the requisite training on the
fi nalized module has occurred before the employee touches
the regulated product.
13.4 The role of the target
audience list
This part addresses four topics. First we will compare and
contrast the purpose of a SOP with the purpose of training
to a procedure. Next we will delineate the role of a Training
Outline as a brief summary of the training implications of a
new or revised SOP. Third, we will present a process map of
the development and utilization of a Training Outline, and
