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),
is a leading provider of regulatory consulting, auditing, and training services
to the global medical device, pharmaceutical, and biologics industries.
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
Our team of
full-time consultants includes former FDA investigators and policy-makers, plus industry experts in quality, compliance, manufacturing,
research, validation, and software development. EduQuest's
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.
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schedule of training classes from
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free monthly e-newsletter,
EduQuest-ions & Answers,
with answers to Frequently Asked Questions from our clients and practical compliance advice.
Need help in
understanding and meeting FDA's rules and expectations?
Email EduQuest for assistance and advice.