Training
One of our most popular
training services is a combined course on 21 CFR Part 11 and the auditing of
computerized systems. As noted above,
EduQuest
was hired by
FDA to train the agency’s field investigators, analysts, and compliance officers
on the inspection of computerized systems. Our staff, therefore, both developed
and presented this important training material to key FDA personnel. We now
offer this same training course to the industry, and are uniquely qualified to
explain to regulated companies exactly what FDA investigators have been trained
to look for in auditing computerized systems and the use of electronic records
and electronic signatures.
We also
have provided detailed inspectional preparedness training, which focuses on the
scope of FDA’s inspectional authority, the approach of FDA investigators, and
how to effectively manage an inspection and respond to investigators’ questions
and document requests. In addition, we have conducted targeted senior
management briefings on such subjects as GMP compliance, 21 CFR Part 11 and
computerized systems validation, inspectional preparedness, and recent trends in
regulatory enforcement.
All of our training programs
are structured to encourage questions and audience participation, and each
student is provided a comprehensive training manual, including copies of all
presentation slides and pertinent reference material.
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