Biomedical Engineering Reference
In-Depth Information
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34R
Final implementation
Abstract:
This chapter reviews the scope and impact of
FDA regulations for the life sciences industry in general,
and for training in particular. Any person who touches the
regulated product, or who supervises that person, falls
within the scope of the regulations. These persons must be
trained on SOPs, insofar as they relate to the employees'
functions, prior to their touching the regulated product.
Thus it is critical that the fi nal implementation of the
training module includes all these employees. Next, a
widely used approach to ensuring that employees are
trained before they touch the regulated product is critically
examined. A supervisor is required by SOP to ensure all
necessary training and qualifi cation requirements in the
employee curricula are completed and documented prior
to assigning an employee to a task. The shortcomings of
such an approach are detailed, especially the failure to
provide the supervisor with necessary information about
the accuracy and currency of the employee curricula.
Finally, an alternative approach involving a controlled
document that includes a Target Audience List is proposed.
This document facilitates the communication necessary to
ensure the requisite training has taken place.
Key words:
business owner, fi nal implementation,
individual training plan (ITP), just-in-time training (JITT),
34R
