1995-2015

EduQuest Recognized for 20 Years

of Helping Drug and Device Makers

Meet FDA Rules and Expectations

October 2015 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 products.

 

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 three-day FDA Auditing of Computerized Systems and Part 11/Annex 11 course, 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 compliance challenges.

 

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 www.EduQuest.net.

 

 

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