Biomedical Engineering Reference
In-Depth Information
■
investigation reports;
■
out-of-specifi cation results.
Management initiates the disqualifi cation process. The QA
department should review and approve any particular
disqualifi cation, as well as review and approve requalifi cation
standards and processes. The training department is
responsible for monitoring disqualifi cation and requalifi cation
events, as well as ensuring that the disqualifi cation and
requalifi cation documents are submitted to the data entry
personnel of the validated training tracking system or, in case
of manual data processing, to the staff of the document
repository.
8.7 Conclusion
While the FDA requires employees who work in controlled
areas to be trained, it also provides latitude for organizations
to develop their own training systems to make sure their
employees are appropriately trained for GXP compliance.
This chapter addressed key considerations in the topic of
employee qualifi cation, a critical kind of training in regulated
industry. It further provided a comprehensive framework for
an organizational approach to employee qualifi cation.
Concepts described in this framework should be incorporated
in the organization's training policy and procedures
addressing employee qualifi cation. These concepts
demonstrate an organized approach to employee qualifi cation,
compliant with regulatory requirements and expectations,
and consistent with modern principles of risk analysis.
A typology of training, ranging from the least complex
kind, awareness training, through training
per se
(which
includes a KTA), employee qualifi cation (training that
