Biomedical Engineering Reference
In-Depth Information
■
maximum size of training classes and method;
■
required time to conduct training;
■
projected future training population.”
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All of these factors should be taken into account in planning
for continuing cGMP training.
7.6 Conclusion
This chapter addressed continuing cGMP training in four
sections. The fi rst section reviewed the statements that FDA
and other regulatory bodies have made in regulations and
guidances regarding continuing cGMP training. The role
that interpretation and risk assessment plays in an
organization's response to gaps (deviations) between the
statements and ongoing behavior was stressed. The second
section considered the “qualifi ed individuals” that deliver
this continuing training, including similarities and differences
between qualifi cation of trainers and qualifi cation of SMEs.
A formal approach to qualifying trainers such as a cGMP
train-the-trainer program was compared to an experiential
approach such as management's judgment that an employee
is qualifi ed to provide training. The experiential approach is
cheaper than the formal approach, but the formal approach
has the merit of reducing variation in employee performance,
as well as facilitating RCA in case of deviations, as the next
chapter will discuss in some detail.
Also, various staffi ng options were examined. The third
section reviewed topics that are suitable for continuing
cGMP training. Sources included cGMP regulations in 21
CFR 211, written procedures required by these regulations,
topics mentioned in several FDA guidances, FDA warning
letters, and the organization's own records of deviations,
