FDA-regulated companies worldwide for 25 years.
is a global team of FDA compliance experts headquartered near Washington, DC.
Founded in 1995 by 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 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.
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
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Most recent update:
January 9, 2020