Biomedical Engineering Reference
In-Depth Information
or may not become the basis of an investigation and RCA.
Whether the record is investigated further depends upon
(possibly a further) risk assessment.
Neither employees nor the organization react to the standard,
the regulation - they respond to the observed gap, in terms of
risk assessments. The record of the observed gap can also
become part of a set of similar records that can be tracked and
trended within the quality management system. If necessary,
the set itself can be investigated further. Again it is not a matter
of reacting to standards, SOPs, or regulations. The organization
is responding to the set of excursions, the set of gaps, as
reported in the set of records. The conclusion of an investigation
can be followed by the development and execution of corrective
actions and preventive actions. At each decision node, the
decision is based on interpretations and also on risk assessments.
The interpretive aspects and risk assessments of this
investigative and remediation process may be more or less
explicit in various areas of the life science industry, but the
underlying need for interpretation and risk assessment remains.
Moreover, since interpretive aspects and risk assessments
underlie any organization's response to compliance issues, no
organization is simply reactive to regulations.
7.3 Who are the qualifi ed individuals?
FDA regulations mandate that “Training in current good
manufacturing practice shall be conducted by qualifi ed
individuals.”
15
Likewise, Health Canada requires that
“Training is provided by qualifi ed personnel.”
16
As Joanne Cochran and Joseph Nally point out, “Since
211.25(a) requires GMP training to be given by qualifi ed
personnel, the company should have a procedure and process
for qualifying trainers.”
17
Such a procedure would list the
