There is always a possibility of an un-announced FDA
inspection. To be protected from exposure to action
by the FDA, your organization should maintain a
state of “audit readiness” at all times.
Compliance must be on-going; a company cannot “cram”
for an inspection. One way to help get ready for an
FDA inspection is to conduct a mock FDA audit.
Conducting a mock FDA audit will allow your staff to
gain experience in preparing, interfacing and
behaving as if they are actually subjected to an FDA
inspection.
Regulatory requirements call for certain
documentation and other demonstrations to prove that
applicable standards are being met. FDA enforcement
actions occur when the evidence necessary to prove
that standards are being met is absent.
The primary goal of a mock FDA audit is to
facilitate FDA audit readiness. A mock audit
provides training on how to behave in front of FDA
inspectors. A mock audit forces the audited
(inspected) organization to react and respond to
challenges in the same manner as they would if the
FDA were conducting the audit (inspection).
Using outside resources (third party) to perform the
mock audit enables independence of the audit team
and also allows staff to gain experience preparing
and interfacing with auditors/inspectors who they
are not familiar with.
Learn how Cimquest's Q-Factors™
can help you create the necessary building blocks
to attain Hi-Q operational excellence.
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Global Compliance Alliance™ is a leading compliance
solution provider across America, Asia, and Europe.
Providing highly qualified Consultants through out the
world, the GCA gives you
the benefits of a global partner capable of dealing with
world wide multi-site projects.
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Compliance Alliance™.
Part
11 White Paper
