Biomedical Engineering Reference
In-Depth Information
Compliance Offi cer Philip Campbell asked “Are the
employees trained?” He further inquired “Are the supervisors
trained?” Finally, he asked “Are there records of that
training, and is it ongoing?”
7
The fact that more than a quarter of these FDA fi ndings
point to problems in training should not come as a surprise.
However, as we have seen, whenever there is a remediation
(CAPA) for any deviation investigation or regulatory
observation, that remediation will usually involve a revision
of procedure or other controlled document, which in turn
almost invariably involves training on the revised SOP. As
Carl Draper, Director of the FDA Offi ce of Enforcement, has
put it, “The implementation of revised SOPs should include
employee training.”
8
So training will be the
indirect
outcome
of a remediation, and will be the focus of some attention in
the follow-up of the CAPA. Thus we expect that any Warning
Letter - directly addressing issues of cleaning, contamination,
lab work, sampling, testing, utilities, whatever - may also
include a call for training, or for better training.
However, it seems that the FDA has come to expect
ineffective training,
9
or inadequate documentation of
training.
10
These expectations, along with the relative ease of
assessing the occurrence and documentation of training via
the ubiquitous tracking systems and learning management
systems (LMSs), make the investigator's focus on these areas
understandable.
13.2.2 Training versus “Re-training”
Recognizing the inadequacy of training does not amount to
a call for “re-training.” There is a substantial difference
between training as an indirect outcome of a CAPA, and “re-
training” as a
direct
outcome of an investigation, as a CAPA
itself. Regulatory investigators quickly recognize the fallacy
