FDA-regulated companies worldwide since 1995:
is a global team of FDA compliance experts headquartered near Washington, DC.
Need help in
understanding and meeting FDA's rules and expectations?
compliance assistance and advice.
Or visit our free
EduQuest-ions & Answers
for searchable answers to many of your toughest FDA challenges -- all answered
by the FDA compliance experts at
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 Rules for
Effective CAPA Systems, Failure Investigations and Complaint Management
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 FDA expects you to structure and use your CAPA system
to take corrective and preventive actions, manage product complaints, and
identify the root cause of non-conformities and deviations. The next class is scheduled
November 3-4, 2016,
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
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
Search this website with the search box below:
Most recent update:
May 2, 2016