EduQuest, Inc. is a leading provider of regulatory consulting, auditing, and training services to the global pharmaceutical, biologics, and medical device industries. EduQuest also provides training to regulatory agency personnel, and was hired by the U.S. Food and Drug Administration (FDA) to train its field investigators, analysts, and headquarters compliance staff on 21 CFR Part 11 and the inspection of computerized systems. Our team of consultants includes former senior FDA officials and industry experts in quality, compliance, manufacturing, clinical research, validation, and software development. EduQuest's areas of expertise include the validation of regulated computer systems, requirements for electronic records and electronic signatures, process control and validation, quality systems, internal auditing, regulatory compliance and enforcement, and the full range of “GxP†(i.e., good manufacturing, good laboratory, and good clinical practice) requirements.
News from EduQuest:
WASHINGTON, Jan. 15, 2014 /PRNewswire/ — EduQuest – which has trained hundreds of FDA inspectors in the past 19 years – is now training FDA-regulated companies to prepare for inspections of their quality systems and automated processes. (Photo: http://photos.prnewswire.com/prnh/20140115/PH46646) A global team of FDA compliance experts based near FDA headquarters in Washington, DC, EduQuest will present FDA Auditing of […]
WASHINGTON, Aug. 16, 2012 — EduQuest has trained hundreds of FDA inspectors; now it's training thousands of those preparing for inspections. A global team of FDA inspection experts, EduQuest is presenting a series of training courses for quality managers and regulatory specialists September 24-28, 2012, at the Hilton Garden Inn in Frederick, Maryland (near Baltimore […]
WILMINGTON, Del., May 9, 2011 — Medical device R&D labs and manufacturers now have a personal resource for answers to the often confusing maze of FDA regulations outlined in the Agency's Quality System Regulations (21 CFR 820). EduQuest – a global team of FDA compliance experts based near Washington, DC – is presenting two national […]
WASHINGTON, Oct. 29, 2010 — EduQuest has trained hundreds of FDA inspectors; now it trains thousands of those being inspected by the Agency. A global team of FDA compliance experts, EduQuest is presenting the "FDA Auditing of Computerized Systems and Part 11" training course for quality managers and regulatory specialists December 7-9, 2010, at the […]
Former FDA Inspectors Now Train Industry to Comply with Latest Rules
Former FDA Inspectors Train Medical Device, Pharmaceutical Companies How to Comply with New FDA Expectations for Quality Systems WASHINGTON, April 5, 2010 — EduQuest has trained hundreds of FDA inspectors; now it trains thousands of those getting inspected. A global team of FDA compliance experts, EduQuest (http://www.EduQuest.net) is presenting a series of training courses for […]
