Biomedical Engineering Reference
In-Depth Information
FDA regulated industries, the need for optimal delivery of
the training is constrained by the requirement that employees
be trained before they “touch” the product.
At fi rst glance, that requirement might seem to be trivial
- just ensure that the training has been delivered “before,”
and be done with it. But the very dynamic of change that has
driven manufacturing technologies as well as e-learning can
create a climate of turbulence in process and procedure that
makes ensuring “before” very dicey, and raises the prospect
of serious compliance consequences if it turns out to be
“after.” The requirement that employees must be trained
before they touch the product becomes especially acute in
the case of fi nal implementation of a training module, when
it is no longer a matter of selecting the trainees as it is in the
case of a pilot. Each and every employee impacted by a new
or revised procedure must be trained. In this chapter we will
examine that problem and consider several approaches to
addressing it.
13.2 Scope and impact of
FDA regulations
The FDA regulations for pharmaceutical manufacturing, set
out in 21 CFR 211, are comprehensive in both scope and
impact. Regarding scope, these regulations provide guidance
for each person engaged in the manufacture, processing,
packing, and holding of a drug product. The phrase “each
person” includes both employees and supervisors.
The phrase “manufacture, processing, packing, and
holding” is also comprehensive - it includes packing and
labeling operations, testing, and quality control of drug
products. In sum we can say the scope of the regulations
includes any person who is (a) touching the drug product, or
