Biomedical Engineering Reference
In-Depth Information
employee's functions prior to their touching the regulated
product. Hence, the importance of ensuring that the fi nal
implementation of the training module includes all these
employees.
Next we considered a typical organizational response to
the need to ensure employees are trained before touching the
regulated product. This takes the form of a procedure
requiring that the supervisor ensures all necessary training
and qualifi cation requirements in the employee curricula are
completed and documented prior to assigning an employee
to a task. We pointed out several problems with this
approach, especially the failure to provide the supervisor
with necessary information about the accuracy and currency
of the employee curricula.
Finally, we presented an alternative response whereby the
Training Outline, a controlled document including a Target
Audience List, is employed by the originator of a new or
revised procedure to communicate with each impacted
functional area to determine which employees require
training. Those employees' curricula are revised to correspond
to the new or revised procedure, ensuring they are trained
on the fi nalized module before touching the regulated
product.
13.6 Notes
1. See Carol Watson and Sanford Temkin (2000); Michael
Jones (2001); and Bob Mosher (2005).
2. See 21 CFR 211.25, “Personnel qualifi cations.”
3. Available from:
www.fda.gov/foi/warning_letters/
archive/g5395d.pdf
4. Available from:
www.fda.gov/foi/warning_letters/
archive/g6159d.pdf
