Google+ FDA Compliance and Quality System Consulting, Training and Regulatory Advice - EduQuest
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SEduQuest's 20th Anniversary of Service to FDA-Regulated Companieserving the regulated community since 1995:

EduQuest is a global team of FDA compliance experts headquartered near Washington, DC.

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

Who is EduQuest?

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

EduQuest provides proven FDA compliance training with 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 on 21 CFR Part 11 and the inspection of computerized systems. 

The president and co-founder of EduQuest, Martin Browning, is the co-author of Part 11 and co-developer of the QSR -- the Quality System Regulation (21 CFR Part 820) -- while serving at FDA Headquarters.

THIS MONTH'S FEATURED LIVE TRAINING CLASS:

Quality Risk Management

for FDA, ISO, and ICH Compliance

Taught by EduQuest Vice President Janis Olson -- a former FDA expert field investigator and now in-demand as an auditor and Quality System advisor for FDA-regulated companies worldwide. Learn how FDA expects you to integrate risk-based thinking throughout the entire lifecycle of your products. The next class is scheduled April 7-8, 2016, near Baltimore and Washington, DC. Get class details here.

Or see the full schedule of all training classes from EduQuest.

Our team of full-time, global consultants includes former FDA investigators and policy-makers, plus experts from private industry. 

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, verification and validation

  • Quality System improvement, including CAPA guidance

  • Response to FDA Warning Letters and other enforcement actions

  • Part 11 and Annex 11 compliance for electronic records and signatures

  • A full range of “GxP” (i.e., good manufacturing, good laboratory, and good clinical practice) compliance services

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: January 21, 2016

Contact EduQuest   


 

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