Biomedical Engineering Reference
In-Depth Information
unreceptive trainee(s);
inadequate training materials;
an unprepared or incompetent trainer;
ineffective interaction of trainee(s) and trainer; or
some combination thereof. 15
For none of these cases would remediation be as simple as
“re-training,” since the trainee would need to be motivated,
the training materials would need to be revised, the trainer
would need to be qualifi ed, or the interaction would need to
be enhanced before the remediation could go forward.
When John Levchuk calls for Reinforcement Training as a
remediation for “future skills defi ciencies,” 16 he indicates
that refi ned or redefi ned training materials may be indicated,
since “usually, only those skills most likely to be forgotten or
suffer compliance erosion over time would be targeted for
inclusion in a periodic reinforcement program.” 17 Moreover,
when he goes on to call for Remedial Training as a remediation
for “acquired skills defi ciency,” he states that it would be
“more appropriate and effi cient if it were targeted to an
incumbent's specifi c skills defi ciencies.” Thus Levchuk is not
calling for “re-training” in either case.
In this part we have reviewed the scope and impact of the
FDA regulations of pharmaceutical manufacturing in
general, and of training in particular, and found them to be
comprehensive. Any person who touches the regulated
product, or who supervises someone who directly touches
the regulated product, falls within the scope of the regulations.
These regulations impact on these persons via written SOPs
that provide comprehensive guidance for dealing with the
inputs, processes, outputs, and the quality control of drug
manufacturing. These employees must be trained on these
procedures insofar as they relate to the employee's functions,
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