Biomedical Engineering Reference
In-Depth Information
level, while content that is domain (or context) specifi c tends
to be appropriate for the NEO program and other, subsequent
regulatory training.
6
Thus the GMP regulations stipulate
that “training shall be in the particular operations that the
employee performs,” which is to say technical training that
tends to be more task specifi c. The regulations go on to say
that training shall also be “in current good manufacturing
practice (including cGMP regulations in this chapter and
written procedures required by these regulations),” which is
to say regulatory training that tends to be more domain
specifi c.
7
Let us consider several examples of domain specifi c
content. The fi rst illustrations involve Occupational Safety
and Health Administration (OSHA) regulations. In any
industry, a presentation of workplace expectations will
include a review of environmental, health, and safety (EHS)
issues that directly impact employees. This review will
ensure, for example, that all employees can respond
appropriately to various industrial safety warnings and
alarms that may be encountered from their fi rst moment
on the site.
8
By way of illustration, OSHA regulations
stipulate that: “Employers shall provide employees with
effective information and training on hazardous chemicals in
their work area at the time of their initial assignment.”
9
Because of the immediate need new employees have for
this information, the NEO program is a good occasion to
present it.
10
As another example, employees must have immediate and
continuing access to Material Safety Data Sheets (MSDS).
The signifi cance of the MSDS for employee safety can be
covered in the NEO program; the process of accessing this
information can be addressed as well. Should the organization
use an electronic document management system (EDMS) to
capture the MSDS, this portion of the NEO program can be
