Biomedical Engineering Reference
In-Depth Information
(FDA) regulations, refresher training may be scheduled more
frequently than on an annual basis, which is why the regulations
and guidance refer to “continuing” cGMP training rather than
referring to “annual cGMP refresher training.”
The decisions that are made about either kind of training
are informed by an implicit or explicit business risk assessment.
The level of top- down support and the scheduling of continuing
cGMP training refl ect a business risk assessment made by
various decision makers in the organization. Moreover,
decisions about the content of the training, in contrast to
mandate and schedule, may also be informed by a quality risk
assessment, an assessment in terms of risk to the safety,
identity, strength, purity, and quality (SISPQ) of the product.
2
Consider an example of business risk assessment, as it
applies at the program level to continuing cGMP training.
Suppose there is a deviation between the number of employees
who have documented attendance at the annual cGMP
refresher training session and the total number of employees
who are required by procedure to attend by the end of the
calendar year. In this case, the alert level is any number of
employees greater than zero, excluding those on medical
leave, etc. The supervisor of an employee who has failed to
attend by the beginning of the December recess will be
alerted by an e-mail message automatically generated by the
organization's learning management system (LMS).
3
Suppose the total number of non-compliant employees is
one. Will this deviation occasion a Notice of Event (NoE)
investigation, and corrective action and preventive action
(CAPA)? No. What about 10 employees? Probably not.
What about a hundred? Perhaps. Even if it does, will the
CAPA be fulfi lled? There have been cases where the corrective
action - simply put, getting the remaining employees trained
within a month - had to be extended until the middle of
February. And there was no preventive action.
