Biomedical Engineering Reference
In-Depth Information
monitoring program, but it is very hard to pin that down to
make training points.
Still another source of topics is the organization's own
documentation of deviations, investigations, CAPAs, and
product quality complaints, as captured in the quality
management system. This documentation can be reviewed
on a periodic basis, say quarterly or even monthly. The
selected record can be worked up and presented in a training
module. These records do not suffer from either of the
shortcomings noted for the FDA warning letters. The
organization's documentation refers to the training audience's
own systems, and some members of the audience may have
been involved in the observation, investigation, and
remediation process. Second, the very demands for
compliance and documentation in the organization's
investigation and remediation SOPs should ensure an
adequate level of detail to make training points.
Take an illustrative example, one that might be a suitable
topic for a quarterly cGMP training session. Recently,
warehouse staff had trouble correctly fi lling out a particular
form. Supervision caught the problem several times, while
countersigning the document. Then supervision missed one,
and it was recorded in the quality management system.
Management was alerted, and requested an investigation of
the problem - was it a matter of employee training, procedure,
form design, or what?
During the investigation, training records were reviewed,
and it was evident that each of the warehouse employees had
been trained on the current version of the SOP by a qualifi ed
trainer. The SOP was reviewed. It looked straightforward on
its face, and because it also covered two other forms for
which no problems had been observed, it was given a clean
bill of health. The form itself was reviewed, in terms of a
checklist.
31
(Table 7.2).
