is a global team of FDA compliance experts headquartered near Washington, DC. --
now celebrating 20 years of service to the regulated community.
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understanding and meeting FDA's rules and expectations?
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Founded in 1995 by
three former senior officials from the U.S. Food and Drug Administration (FDA),
is an internationally recognized and respected provider of regulatory consulting, auditing, and training services
to the medical device, pharmaceutical, and biologics industries.
hands-on, interactive FDA compliance and quality system training to regulated
companies through a series of popular face-to-face classroom courses presented
around the world. In addition, EduQuest has been selected 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.
areas of expertise include internal auditing (including conducting Mock FDA
Audits), inspection preparedness, supplier management and auditing, validation
of software and regulated computer systems, design control and validation, process control, quality systems, regulatory compliance, response to
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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EduQuest-ions & Answers,
with answers to Frequently Asked Questions from our clients and training class
Most recent update:
November 9, 2015