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EduQuest is a global team of FDA compliance experts headquartered near Washington, DC. -- now celebrating 20 years of service to the regulated community.

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

Or visit the EduQuest-ions & Answers information center for indexed, search-able FDA compliance and inspection guidance.

Founded in 1995 by three former senior officials from the U.S. Food and Drug Administration (FDA), EduQuest is an internationally recognized and respected provider of regulatory consulting, auditing, and training services to the medical device, pharmaceutical, and biologics industries. 

EduQuest provides hands-on, interactive FDA compliance and quality system training to regulated companies through 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, analysts, and headquarters compliance staff on 21 CFR Part 11 and the inspection of computerized systems. 

THIS WEEK'S FEATURED LIVE TRAINING CLASS: The CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations and Complaint Management, taught by EduQuest Vice President Denise Dion, who was an expert FDA field investigator for 18 years and has advised EduQuest clients worldwide on how to improve their Quality Systems during the past 10 years. The next CAPA Clinic training class is scheduled October 1-2, 2015, near Baltimore and Washington, DC. Get class details here.

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

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 (including conducting Mock FDA Audits), inspection preparedness, supplier management and auditing, validation of software and regulated computer systems, design control and validation, process control, quality systems, regulatory compliance, response to FDA Warning Letters and other enforcement actions, and the full range of “GxP” (i.e., good manufacturing, good laboratory, and good clinical practice) requirements.

For on-going FDA compliance advice and updates,  subscribe to EduQuest's free monthly e-newsletter, EduQuest-ions & Answers, with answers to Frequently Asked Questions from our clients and training class Alumni.

Most recent update: August 4, 2015

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