FDA-regulated companies worldwide since 1995:
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Founded in 1995 by three former
senior officials from the U.S. Food and Drug Administration (FDA),
is an internationally respected provider of regulatory consulting, auditing, and training services
for the medical device, pharmaceutical, biologics, and other FDA-regulated industries.
proven FDA compliance training
with 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 on 21 CFR Part 11 and the inspection of
The president and
Martin Browning, is the co-author of Part
11 and co-developer of the QSR -- the Quality System Regulation (21 CFR Part
820) -- while serving at FDA Headquarters.
FEATURED LIVE TRAINING CLASS:
FDA's 21 CFR 820 Quality System Regulation for Medical Devices
Vice President Denise Dion -- a former FDA expert field investigator and now
in-demand as an auditor, trainer and Quality System advisor for
FDA-regulated companies worldwide. Learn how to develop a by-the-book
Quality Management System for medical device design, production, validation,
change control, and inspection preparation. The next class is scheduled
September 18-19, 2017,
near Baltimore and Washington, DC.
Get class details here.
Our team of
full-time, global consultants includes former FDA investigators and policy-makers, plus
experts from private industry.
areas of expertise include:
auditing, including conducting Mock FDA
management and auditing
of software and regulated computer systems
control, verification and validation
improvement, including CAPA guidance
Letters and other enforcement actions
Part 11 and
Annex 11 compliance for electronic records and signatures
A full range of
“GxP” (i.e., good manufacturing, good laboratory, and good clinical
practice) compliance services
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Most recent update:
September 7, 2017