Biomedical Engineering Reference
In-Depth Information
9.1 Introduction
Employees in regulated industries must be trained before
they “touch” the product. According to the US Food and
Drug Administration (FDA), each employee must have the
“education, training, and experience, or any combination
thereof, to enable that person to perform the assigned
functions.”
1
This requirement has substantial implications
for both managers and regulators. It also has substantial
implications for the assessment of trainee profi ciency.
Education and experience are dealt with differently than
training. Education is typically documented in terms of grade
level completed by - or diplomas awarded to - students in
accredited institutions on the basis of a series of learning
experiences over an extended period of time.
2
Experience
typically refers to work experience, and is documented by
the employee's length of time in a specifi c job position; often
that is an extended period of time.
3
None of these measures
is entirely adequate; in both work experience and education,
the qualitative richness of the process is obscured by the
measure of duration. But they provide guidance to corporate
policy nonetheless.
The pharmaceutical or other regulated company seeks
to ensure that employees have requisite educational
attainment by effectively implementing recruitment
policies or HR policies in support of continuing education.
The company can either recruit employees who meet
educational levels or can subsidize the employees' further
education until they meet the desired level. Likewise,
the company strives to ensure that employees have the
requisite work experience. The company can either recruit
employees who have specifi c work experience or can retain
employees until they acquire the desired level of on-the-job
experience.
