Biomedical Engineering Reference
In-Depth Information
evaluation of training needs;
provision of training to satisfy these needs;
evaluation of effectiveness of training;
documentation of training and/or re-training.
When operating in a robust quality system environment,
it is important that managers verify that skills gained from
training are implemented in day-to-day performance. 3
FDA has thereby provided an opening for each organization
in regulated industry to develop its own training system that
will ensure that its employees are appropriately trained for
GXP compliance.
One often overlooked functional area where the use of
standard operating procedures (SOPs) makes good business
sense is in employee training. The development of a half-
dozen or so training system SOPs - providing guidance for a
number of areas such as task analysis, design and development
of training and assessment materials, program rollout and
evaluation, SME qualifi cation, structured on-the-job trainer
(SOJT) qualifi cation, training advisory council of middle
managers, and training metrics - would go a long way
toward economizing an organization's training resources.
Some suppose that these SOPs would add to the “training
burden” of the organization; our experience strongly suggests
that the “burden,” such as it is, derives from the very absence
of procedures. While training is a regulatory requirement,
there is no requirement for the use of SOPs to guide and
structure those training activities.
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8.3 Categories of training
Before discussing qualifi cation of employees for GXP
compliance, let us fi rst describe the respective categories and/
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