Biomedical Engineering Reference
In-Depth Information
walking through the facility, examining current records,
interviewing employees, etc.
When “defi ciencies” are observed, they are reported to
management before FDA personnel has left the facility. These
Form 483 observations can later become part of an
FDA Warning Letter to the management of the organization.
At that point, if not earlier, the organization will begin
to respond. The response typically includes management's
call for an investigation of each defi ciency observed
during the inspection. Each investigation will include RCA,
and tracking and trending of similar events or situations
observed elsewhere or in prior inspections. CAPA will
be developed and executed, all within a specifi ed
timeline. The remediation may require the revision of an
operational SOP.
1.5.2 Adverse event
A second kind of observation is associated with an
adverse event (AE). With respect to drugs, FDA has
defi ned an AE as “any adverse event associated with the use
of a drug in humans, whether or not considered drug
related.” 22
Again with respect to drugs, a serious adverse event (SAE)
is further defi ned by the FDA as:
￿ ￿ ￿ ￿ ￿
. . . any adverse drug experience occurring at any
dose that results in any of the following outcomes:
death, a life-threatening adverse drug experience,
inpatient hospitalization or prolongation of existing
hospitalization, a persistent or signifi cant disability/
incapacity, or a congenital anomaly/birth defect.
Important medical events that may not result in
death, be life-threatening, or require hospitalization
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