Google+ FDA Compliance Training, Consulting and Regulatory Advice
image
image
image
image

Serving FDA-regulated companies worldwide for 22 years.

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 an internationally respected provider of regulatory consulting, auditing, training, and validation services for all FDA-regulated industries. 

EduQuest provides a full schedule of 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.

Visit our free EduQuest-ions & Answers Information Center for searchable answers to many of your toughest FDA challenges -- all answered by the FDA compliance experts at EduQuest.

FEATURED LIVE TRAINING CLASS:

Managing & Auditing Supplier Quality:

FDA Expectations, Global Standards,

and Real-World Solutions

Taught by EduQuest President and Co-Founder Martin Browning -- a former FDA field investigator and now in-demand as an auditor, trainer and Quality System advisor for FDA-regulated companies worldwide. Learn how  FDA expects you to evaluate, audit and manage the various levels of your supply chain to ensure their quality matches your own commitment to quality. The next class is scheduled May 17-18, 2018, near Baltimore and Washington, DC. Get class details here.

Or see the complete EduQuest schedule of training classes.

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

Our 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.

Search this website with the search box below:

 

Most recent update: October 24, 2017

Contact EduQuest   


 

image
About EduQuest
image
ABOUT US


EduQuest Services
image
SERVICES


Current EduQuest Courses
image
CURRENT COURSES


FDA Compliance Library
image
FDA COMPLIANCE LIBRARY
image

image

image
image