Biomedical Engineering Reference
In-Depth Information
necessary steps (tasks) that, taken together, are suffi cient to
produce the desired outcome of the process, namely the
qualifi ed trainer.
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7.3.1 Qualifi cation of SMEs versus trainers
The qualifi cation of trainers is a specifi c instance of the more
general process of qualifying subject matter experts (SMEs).
As such, the SOP and process for qualifying trainers will be
homologous to the SOP and process for the qualifi cation of
SMEs. (The qualifi cation of SMEs will be discussed in the
next chapter.) This is not to say that SMEs can be confl ated
with trainers. There are substantial differences between the
two, even though a master trainer can be considered an
expert in the subject matter of training.
Crucial differences exist between the kind of process
requiring the qualifi cation of a SME and the kind of process
(i.e., a GMP training process) requiring the qualifi cation of a
trainer. A SME must be qualifi ed, if the following relevant
procedure or process:
■
involves high skill level, complex activity or application of
advanced knowledge or logic;
■
is performed in the direct manufacturing of a
pharmaceutical product;
■
involves the quality attributes (SISPQ) of the product;
■
has serious consequences for the batch, negative impact
on the patient, or injury to the operator in the case of error
or deviation.
These criteria clearly refl ect aspects of criticality and
complexity that go into risk assessment. By contrast, a trainer
must be qualifi ed to present any cGMP training, regardless
of complexity and criticality.
