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EduQuest
is a global team of FDA compliance experts headquartered near Washington, DC.
Founded in 1995 by
three former senior officials from the U.S. Food and Drug Administration (FDA),
EduQuest
is a leading provider of regulatory consulting, auditing, and training services
to the global medical device, pharmaceutical, and biologics industries.
EduQuest provides
hands-on, interactive training to industry and regulatory agency personnel and was hired by the
FDA and Health Canada to train agency field investigators, analysts,
and headquarters compliance staff on 21 CFR Part 11 and the inspection of
computerized systems.
Our team of
full-time consultants includes former FDA investigators and policy-makers, plus industry experts in quality, compliance, manufacturing,
auditing, clinical
research, validation, and software development. EduQuest's
specific
areas of expertise include internal auditing, inspection preparedness, supplier
management and auditing, validation of regulated computer systems,
requirements for electronic records and electronic signatures, process control
and validation, quality systems, regulatory compliance, response to Warning
Letters and other enforcement actions, and the full range of “GxP” (i.e., good manufacturing, good
laboratory, and good clinical practice) requirements.
Click here for the latest
schedule of
EduQuest
training classes.
Click here to subscribe to
EduQuest's
free monthly e-newsletter, EduQuest-ions & Answers, offering answers to
Frequently Asked Questions from our clients and practical compliance advice.
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