Biomedical Engineering Reference
In-Depth Information
investigations, CAPAs, and product quality complaints. The
fi nal section addressed the logistics of such training, including
the frequency with which cGMP training should be delivered,
concluding that FDA recommends training more frequently
than just on an annual basis.
7.7 Notes
1. See OSHA, 29 CFR 1910.134(k) Respiratory Protection,
“The employer [is required] to provide effective training
to employees who are required to use respirators. The
training must be comprehensive, understandable, and
recur annually, and more often if necessary.” See also
∫1910.134(k)(5), “Retraining shall be administered
annually.”
2. For the distinction between quality risk assessment
and business risk assessment, see Chris Enyinda,
Charles Briggs and Khalid Bachkar (2009); for the
distinction in the GLP context, see Alain Piton, (2008);
for the distinction in the GCP context, see Sherri A.
Hubby (2009).
3. On the one hand, such an e-mail message would be
exempt from Part 11 considerations. Among the few
training related predicate rules that are covered by 21
CFR 11,
Electronic Records; Electronic Signatures
, is 21
CFR 111.14(b)(2), which stipulates “Documentation of
training, including the date of the training, the type of
training, and the person(s) trained,” relating to GMPs
for Dietary Supplements. [Published in the
Federal
Register
, Vol. 72, No. 121, 25 June 2007, p. 34810].
However, the message itself can include the proviso that
“This message is not a GMP document; for GMP
purposes, refer to the source document in the LMS,” etc.
