Biomedical Engineering Reference
In-Depth Information
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34R
Content development: a new
employee orientation program
Abstract:
This chapter addresses the development of a
new employee orientation (NEO) program for GXP
compliance. There are two major sets of organizational
expectations for the workplace performance of a new
employee - compliance and productivity expectations.
These expectations are operative from the new hire's fi rst
moment on the job, hence NEO is a timely setting for
presenting these expectations. This chapter reviews the
Employment Life-cycle, the comprehensive process
every employee goes through from recruitment to
separation, and situates NEO in that life-cycle. Next,
various features of a typical NEO program are sketched.
Then a scenario-based discussion of regulatory overlap is
presented, as well as appropriate employee responses.
This is followed by an episodic approach to the history of
the FDA. These episodes are employed as illustrations of
the process of continuous improvement (i.e., identifi cation
of problems (deviations), investigation and root cause
analysis, and remediations). Finally, several aspects of the
organization of the NEO program are presented, including
the necessity to coordinate the program across several
departments.
34R
