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EduQuest 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), EduQuest is a leading provider of regulatory consulting, auditing, and training services to the global medical device, pharmaceutical, and biologics industries. 

EduQuest provides hands-on, interactive training to industry and regulatory agency personnel and was hired by the FDA and Health Canada to train agency field investigators, analysts, and headquarters compliance staff on 21 CFR Part 11 and the inspection of computerized systems. 

Our team of full-time consultants includes former FDA investigators and policy-makers, plus industry experts in quality, compliance, manufacturing, auditing, clinical research, validation, and software development. EduQuest's specific areas of expertise include internal auditing, inspection preparedness, supplier management and auditing, validation of regulated computer systems, requirements for electronic records and electronic signatures, process control and validation, quality systems, regulatory compliance, response to Warning Letters and other enforcement actions, and the full range of “GxP” (i.e., good manufacturing, good laboratory, and good clinical practice) requirements.

Click here to see the latest schedule of training classes from EduQuest.

Click here to subscribe to EduQuest's free monthly e-newsletter, EduQuest-ions & Answers, with answers to Frequently Asked Questions from our clients and practical compliance advice.

Need help in understanding and meeting FDA's rules and expectations? Email EduQuest for assistance and advice.

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ABOUT US


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CURRENT COURSES


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FDA Compliance Library
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