Biomedical Engineering Reference
In-Depth Information
separation. This chapter reviewed the Employee Life-cycle,
and various features of a typical NEO program were treated.
A scenario-based discussion of regulatory overlap was
presented, as well as appropriate employee responses. This
was followed by an episodic approach to the history of the
FDA. These episodes were employed as illustrations of the
process of continuous improvement (i.e., identifi cation of
problems (deviations), investigation and RCA, and
remediations). Finally, several aspects of the organization of
the NEO program were presented, including the necessity to
coordinate the program across several departments.
6.8 Notes
1. See Keith Rollag (2007).
2. See B. M. T. (2008).
3. John P. Wanous and Arnon E. Reichers (2000). For
further discussions of NEO programs, see Doris Sims
(2001) and Karen Lawson (2002).
4. For checklists of topics included under resources and
information, see Kathryn Tyler (1998) or David K. Lindo
(1999). The new employee orientation program should
not be restricted to these HR activities; as Garvey has
pointed out, recent “NEO initiatives are getting more
creative and comprehensive, and they are moving away
from those painful sessions with stacks of HR forms and
dusty videos.” See Charlotte Garvey (2001).
5. Keith McFarland (2006).
6. Thus it is a GXP requirement that employees must be
appropriately gowned for an assignment in a limited
access area of the site, but gowning procedures may
vary in terms of different limited access areas. For
gowning in GMP sites, see 21 CFR 211.28(a), for
