Biomedical Engineering Reference
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34R
Content development: a
continuing cGMP training
program
Abstract: As a second example of the content of training
materials, this chapter discusses continuing current good
manufacturing practice (cGMP) training in four sections.
The fi rst section reviews statements taken from regulations
and guidances about continuing GMP training, made by
the US Food and Drug Administration (FDA) and other
regulatory bodies. The interpretive nature of these
statements, and the role that risk assessment plays in
organizational response to gaps (deviations) between the
statements and ongoing behavior, are stressed. The second
section addresses the topic of individuals who are qualifi ed
to deliver the continuing GMP training, presenting two
approaches to qualifying trainers - a formal approach such
as a GMP train-the-trainer (TTT) program and an
experiential approach. While the experiential approach is
cheaper than the formal approach, the formal approach
has the merit of reducing variation in employee performance,
as well as facilitating root cause analysis (RCA) in case of
deviations. The third section reviews major sources of
topics that are available for continuing cGMP training,
including regulations in 21 CFR 211, written procedures
required by these regulations, and topics mentioned in
￿ ￿ ￿ ￿ ￿
34R
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