Biomedical Engineering Reference
In-Depth Information
conducted in a networked computer classroom, where the
new employees can be stepped through the process of logging
on to the organization's intranet, accessing the EDMS, and
retrieving a MSDS. The presentation of employee safety
issues in a NEO program is typically facilitated by a
representative of the EHS unit.
In FDA-regulated industry, another presentation of
workplace expectations will include a review of relevant
GXP regulations to ensure that the employee will be
compliant in each assigned task according to regulations,
corporate policies, and local procedures. Again, these
compliance issues may arise from the fi rst moment the
employee is on the site. This GXP review will ensure, for
instance, that the new employee is “instructed to report to
supervisory personnel any health conditions that may have
an adverse effect on drug products.”
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An important topic that should be covered in the GXP
review is the FDA requirement that employees have
immediate and continuing access to relevant SOPs. Good
laboratory practice (GLP) regulations, for instance, stipulate
that “each laboratory area shall have immediately available
laboratory manuals and standard operating procedures
relative to the laboratory procedures being performed.”
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Because new employees may have an immediate need to
access procedures, the NEO program is a timely occasion to
address this issue.
For example, a newly hired Animal Care Technician must
have immediate access to the lab's procedures for the
identifi cation of test animals. The process of accessing this
information can be addressed in the NEO program.
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If the
lab makes the SOPs available in an EDMS, this part of the
GLP review can be conducted in a networked computer
classroom, where the technician can go through the process
of logging on to the organization's intranet, accessing the
