Biomedical Engineering Reference
In-Depth Information
Table 8.1
FDA regulations for employee training
Regulation
Regulated personnel
21 CFR 58.29
Non-clinical lab personnel
21 CFR 110.10
Human food handlers personnel
21 CFR 113.10
Thermally processed food handlers
21 CFR 114.83
Acidifi ed food processing handlers
21 CFR 120.13
HACCP systems managers
21 CFR 123.10
HACCP systems managers
21 CFR 211.25
Pharmaceutical personnel
21 CFR 225.10
Medicated feed personnel
21 CFR 600.10
Biological products personnel
21 CFR 606.20
Blood component personnel
21 CFR 820.25
Medical device personnel
21 CFR 1271.170
Human tissue recovery personnel
in [. . .] a nonclinical laboratory study shall have education,
training, and experience, or combination thereof, to enable
that individual to perform the assigned functions.” 1 This
requirement is repeated, with slight variation in phrasing, for
other regulated areas (Table 8.1). FDA regulations say little
more about training requirements. According to John Levchuk
of the FDA, “The FDA has not published a guideline establishing
acceptable procedures for personnel training, nor is a guideline
being planned.” This point was reiterated by Vasilios Frankos,
who stated, “At this time we have no plans to provide
companies with training materials for their employees.” 2
￿ ￿ ￿ ￿ ￿
Several FDA guidances for industry provide more direction
for training. In the Quality Systems Approach to Pharmaceutical
cGMP Regulations , for example, FDA indicates:
Under a quality system, managers are expected to
establish training programs that include the following:
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