Biomedical Engineering Reference
In-Depth Information
FDA guidances, FDA warning letters, and the organization's
own records of deviations, investigations, corrective actions
and preventive actions, and quality complaints. The fi nal
section reviews a major logistical issue in the delivery of
continuing cGMP training: the frequency with which this
training should be scheduled. FDA recommends training
more frequently than just on an annual basis.
Key words:
business risk assessment, cGMP requirements,
continuing GMP training, FDA warning letters,
qualifi cation of SMEs, qualifi cation of trainers, qualifi ed
individuals, quality risk assessment, review of forms.
7.1 Introduction
Every organization in regulated industry must train its
employees. This training is scheduled in several ways. There
is a basic scheduling distinction between training that is
delivered in response to a perceived defi ciency in performance
or qualifi cation, and training delivered according to the
calendar. Training according to defi ciency in performance or
qualifi cation includes new employee orientation (NEO),
training for business process redesign and standard operating
procedure (SOP) revision, and most technical training. In
each case, trainees lack skill, information, or motivation that
can be remedied by the training intervention.
Training according to the calendar includes much of
regulatory training - the periodic refresher training that is
mandated in business ethics, non-harassment policies, non-
discrimination policies, a number of Occupational Safety and
Health Administration (OSHA) regulations,
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and current good
manufacturing practice (cGMP) regulations. As will become
clear in the case of the US Food and Drug Administration
