Biomedical Engineering Reference
In-Depth Information
harder to turn a professional trainer into a technically savvy
trainer than it is to turn a SME into a trainer.”
22
But there is a third option. Vesper points out that,
“sometimes it is diffi cult to fi nd good trainers who also have
solid experience or knowledge in a particular technical
area.”
23
He goes on to say, “that is an excellent opportunity
for co-teaching: an experienced instructor helping to lead the
formal sections of the course and the expert serving as a
resource to relate experiences and answer questions.” He
concludes that “if a co-teaching approach is used, both people
should be qualifi ed as a team, and that should be provided for
in your training SOP.”
24
Developing a training team consisting
of a qualifi ed trainer and a SME is a most effective way to
address the staffi ng challenge in the short term.
7.4 Applicable cGMP requirements
The FDA regulations stipulate that the training will “assure
that employees remain familiar with cGMP requirements
applicable to them.” What are those “applicable
requirements”? Conceptualize the regulatory framework as
a pyramid, with the cGMPs at the top, corporate policies
making up the next tier, divisional standards as a further tier,
and local SOPs as the lower tier.
25
Then the applicable
requirements are those that fi lter down from the cGMPs and
are refracted in the local procedures (Figure 7.1).
Topics for continuing cGMP training include not only the
regulations in 21 CFR 211, as refracted to the local level, but
also any “written procedures required by these regulations,
as they relate to the employee's functions.”
26
Those written
procedures include the following see (Table 7.1).
Suggested topics for continuing cGMP training are also
given in several guidances. For example, the
Quality Systems
