Biomedical Engineering Reference
In-Depth Information
EDMS, and retrieving the relevant SOP. Access to this
material is typically facilitated by PharmOps staff.
In addition to the OSHA and FDA regulatory areas, other
corporate policies addressing workplace expectations -
topics such as security, intellectual property rights, and
corporate intranet access - must be presented.
This section sketched out a typical NEO program,
highlighting program elements that address regulatory issues
and, in particular, GXP regulations. The next section will
discuss regulatory overlap, and suggest ways this can be
addressed in a NEO program.
6.4 Regulatory overlap and its
implications
Another important topic that should be covered in the NEO
program is the complexity of regulatory regimes and
regulations that impact the organization, as well as the
individual employees. These regimes include such agencies as
the FDA, DEA, DOT, EPA, OSHA, and others, each with its
own set of regulations. As already noted, the new hire or
transferred employee may have an employment background
that was not subject to regulation by some of these agencies,
or to such complexity of regulation.
On the one hand, the sheer number of these disparate
regulations means that they cannot be considered in any detail
in the NEO program. They will need to be addressed, on a
timely but “as needed” basis, during training subsequent to
NEO. However, the various regimes can present the problem
of regulatory overlap, where different agencies have differing
regulations covering the same situation. This complexity can
be raised during NEO, and several ways the affected employee
can appropriately respond can be highlighted.
￿ ￿ ￿ ￿ ￿
Search WWH ::




Custom Search