Recognized for 20 Years
of Helping Drug and Device Makers
Meet FDA Rules and Expectations
was the 20th
anniversary of EduQuest providing expert advice and training to the world’s
top drug and device-makers and other FDA-regulated industries.
EduQuest was created in 1995 by three
former Food and Drug Administration officials with experience as rule-makers
and expert field investigators.
Martin Browning, who co-founded the company with Tom Johnson and Jay
Allen, continues to serve as the company president.
“It’s hard to believe it’s been
more than 20 years,
but throughout the entire time EduQuest’s mission has never changed,” said
Browning. “By combining consulting and teaching, we’ve genuinely tried to
help FDA-regulated companies do the right things – resulting in safer
products for all of us.”
During his 22-year career at the FDA,
Browning co-wrote FDA’s 21 CFR Part 11 rules for electronic records and
signatures and helped to develop FDA’s Quality System Rule (QSR), which
governs the design and manufacture of medical device and diagnostic
EduQuest’s company name is a composite of
the words Education, Quality, Engineering, Science and Technology,
reflecting the company’s commitment to education and scientifically sound
principles, especially in the development of quality systems and the
validation of computer systems and operating processes.
One of the company’s very
first training projects continues to this day. In 1995, the FDA hand-picked
EduQuest to develop and present to FDA field inspectors a series of classes
for evaluating the regulatory compliance of computerized systems. Twenty
years later, EduQuest still offers a variation of that class with the
FDA Auditing of Computerized Systems and Part 11/Annex 11
which has trained thousands of students in private industry.
EduQuest also continues to train FDA
inspectors and agency officials with 25 online courses delivered through ORA-U,
the web-based learning platform for FDA’s Office of Regulatory Affairs.
In addition to the FDA Auditing of
Computerized Systems class,
other classes taught by EduQuest cover quality
systems, supplier auditing, risk management, design control, and good
manufacturing, laboratory and clinical practices. EduQuest also conducts
custom-designed courses at client sites in the U.S. and overseas.
As consultants, one of the EduQuest’s
most in-demand services is the Mock FDA Audit. In the mock audit, EduQuest
authorities visit a client facility to assess the facility’s processes,
policies and procedures, applying many of the same inspection approaches and
protocols used by the FDA.
To help its clients adopt industry best
practices and keep up with regulatory changes at the FDA, EduQuest also
publishes a free monthly e-newsletter,
EduQuest-ions & Answers,
in which its experts answer Frequently Asked Questions about various FDA
Details about EduQuest’s training and
mock FDA audit services – including a full schedule of the company’s
training classes and a sign-up form for the company’s monthly e-newsletter –
are available at
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