Biomedical Engineering Reference
In-Depth Information
provide any instances of such problems, the FDA warning
letters might give additional weight to the training points.
A fi nal point about applicable cGMP requirements is the
relevance and effectiveness of particular cGMP training for
various groups within an organization's workforce. In
Q9,
Quality Risk Management
, the ICH has suggested that a
potential use of quality risk management principles and tools
may be “to determine the appropriateness of [. . .] ongoing
training sessions based on education, experience, and
working habits of staff.”
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Trainees can be grouped according
to their task assignments. For example, employees who
check batch records need not be given the same continuing
cGMP training module as operators, even though both
groups may be governed by the same broad set of procedures.
Their workplace focus is much different. Likewise, ICH
recommends that the appropriateness of continuing training
be determined by “a periodic assessment of previous training
(e.g., its effectiveness).”
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7.5 Logistics of continuing
cGMP training
Having discussed the regulatory requirements for continuing
cGMP training, the necessity of using qualifi ed trainers to
deliver the training, and the topics that could make up the
training content, it is time to turn to the logistics of this
training. The main logistical question is: How frequently
should this continuing training be scheduled?
FDA regulations do not stipulate the frequency of continuing
training, but recommendations are available in guidances.
For example, the
Current Good Manufacturing Practice for
Medical Gases
indicates that, “FDA recommends that cGMP
training not be conducted in one massive training session.
