Biomedical Engineering Reference
In-Depth Information
3. On SOJT, see William Rothwell and H C Kazanas
(2004); also Ronald L Jacobs (2003).
4. See 21 CFR Part ∫ 211.25, “Personnel qualifi cations.”
5. See 21 CFR Part ∫ 211.28, “Personnel responsibilities.”
Also Jan Eudy (2004).
6. See, for example, Lawrence Bierlein (1998); also Bierlein
(2005); and Shadid Jamil, H.L. Floyd, and D. Pace
(1999). There are also state laws and regulations that
must be taken into account; see A. Bender, N. Shannon,
and J. Braun-Davis (2005).
7. For instance, the chain of custody required by DEA 21
CFR Part ∫ 1301.73, “Physical Security Controls . . .”
and the evacuation requirements of OSHA 29 CFR
∫ 1910.38(c), “Emergency Action Plans.” See also
National Academy of Sciences/ Institute of Medicine
(1998). See Society of the Plastics Industry (1998):
over the years, the food packaging industry has been
subjected to an undue burden as a result of the
regulatory overlap among FDA, USDA, and the
Bureau of Alcohol, Tobacco, and Firearms (BATF);
and “FDA Cancels Part 11 Meeting,”
Part 11 Compliance
Report
(9 June 2004), Vol. 4, No. 12, p. 2, for a discussion of
the regulatory overlap between 21 CFR Part 11 and other
regulations affecting life science companies, such as HIPAA
and Sarbanes-Oxley. For an overview, see Robert W. Hahn
(1988).
8. See 29 CFR ∫ 1910.147, “Control of hazardous energy.”
This standard mandates that each workplace, with few
exceptions, must develop a program to “disable
machinery or equipment and prevent the release of
potentially hazardous energy while maintenance and
servicing are being performed.” Hazardous energy
includes electrical, mechanical, hydraulic, pneumatic,
