FDA-regulated companies worldwide for 22 years.
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 an internationally respected provider of
validation services for all FDA-regulated industries.
EduQuest provides a
full schedule of 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.
Visit our free
EduQuest-ions & Answers
for searchable answers to many of your toughest FDA challenges -- all answered
by the FDA compliance experts at
FEATURED LIVE TRAINING CLASS:
FDA Expectations, Global
and Real-World Solutions
President and Co-Founder Martin Browning -- a former FDA field investigator and now
in-demand as an auditor, trainer and Quality System advisor for
FDA-regulated companies worldwide. Learn how FDA expects you to
evaluate, audit and manage the various levels of your supply chain to ensure
their quality matches your own commitment to quality. The next class is scheduled
May 17-18, 2018,
near Baltimore and Washington, DC.
Get class details here.
EduQuest schedule of training
full-time, global consultants includes former FDA investigators and policy-makers, plus
experts from private industry.
Our specific 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
For on-going FDA
compliance advice and updates, subscribe
free monthly e-newsletter,
EduQuest-ions & Answers,
with answers to Frequently Asked Questions from our clients and training class
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Most recent update:
January 16, 2018