Biomedical Engineering Reference
In-Depth Information
The only requirement for documentation of training is
found in FDA GLPs, where it is stipulated that “Each testing
facility shall maintain a current summary of training and
experience and job description for each individual engaged
in or supervising the conduct of a nonclinical laboratory
study.”
18
That implicates a “current summary” of the
individual's training records, which might take the form of
the individual's training history, not the training records or
training assessments themselves.
Regarding clinical trials, FDA stipulates that:
A protocol is required to contain the following [. . .]
The name and address and a statement of the
qualifi cations (curriculum vitae or other statement of
qualifi cations) of each investigator, and the name of
each sub-investigator (e.g., research fellow, resident)
working under the supervision of the investigator
on a given clinical study.
19
Notice that this predicate rule
about “curriculum vitae or other statement of qualifi cations”
of the clinical trials investigator was not extended to the
subordinates, the research fellows, residents, etc.
Finally, the GMPs require “records shall be maintained
stating the name, address, and qualifi cations of any
consultants and the type of service they provide.”
20
It is
instructive that the rule-making that applied this predicate
rule to the qualifi cations of consultants did not apply it to
the majority of pharmaceutical operations employees and
supervisors covered in 21 CFR 211.25.
FDA regulations are silent about training records for other
areas such as pharmaceutical and biopharmaceutical
operations, medical device operations, blood products
processors, or human tissue processors.
21
Indeed, CFR Part
11 does not include such a requirement for itself. It requires
