EduQuest — a global team of FDA compliance experts headquartered near Washington, DC — has been providing advice, training and inspection tips to FDA-regulated companies worldwide since 1995.
Founded by three former FDA investigators and policy-makers, EduQuest continues to share its expertise and hands-on experience with consulting assignments, mock FDA audits, training classes and webinars, and this EduQuest-ions & Answers Information Center, which provides an indexed, search-able collection of the Q&As published by EduQuest in its monthly e-newsletter to clients since 2010.
EduQuest provides proven FDA compliance training with a series of popular face-to-face classroom courses presented around the world. In addition, EduQuest was been selected by the FDA and Health Canada to train Agency field investigators on 21 CFR Part 11 and the inspection of computerized systems to ensure data integrity.
The president and co-founder of EduQuest, Martin Browning, is the co-author of the Part 11 regulation for electronic records and electronic signatures and a contributor to the development of the QSR — the Quality System Regulation (21 CFR Part 820) — during his 22-year service at FDA.
You can get further details about the consulting and training services provide by EduQuest experts at the About EduQuest section of this Q&A Information Center or by visiting our primary website, www.EduQuest.net.