Biomedical Engineering Reference
In-Depth Information
with Stent-Making Practices at Florida's Cordis,”
Miami
Herald
, 6 April 2004.
9. Available from:
www.fda.gov/foi/warning_letters/
s6341c.htm
10. Available from:
www.fda.gov/foi/warning_letters/
g6208d.htm
11. Available from:
www.fda.gov/foi/warning_letters/
archive/g5973d.htm
12. Available from:
www.fda.gov/foi/warning_letters/
archive/g5973d.htm
13. See Laurie Fischer (2006); also Ellie Myler (2006) and
Tina Torres (2006).
14. Authorization involves authenticated users; usually
this is two-factor authentication involving two of
the threefactors: (a) What you know (e.g., a
password), (b) What you have (e.g., a security swipe
card), and (c) What you are (e.g., a biometric
characteristic).
See
Joan
Engebretson
(2006);
Bruce Schneier (2005).
15. On predicate rules, see Tammala Woodrum (2003). See
21 CFR 211.198 (a) on the requirement of written
SOPs, 211.198 (b) on the requirement of written records
for each complaint, and 211.198 (b) (2) and (3) on the
requirement of written records for each investigation or
the decision not to investigate.
16. For GLPs, see 21 CFR 58.63, “Maintenance and
calibration of equipment;” for GMPs, see 21 CFR
211.67, “Equipment cleaning and maintenance;” also
21 CFR 211.182, “Equipment cleaning and use log;”
and for medical devices, see 21 CFR 820.70, “Production
and process controls.”
17. For pharmaceutical employees, see 21 CFR 211.25;
for biopharm personnel, 21 CFR 600.10; for non-
clinical lab personnel, 21 CFR 58.29; for medical
