EduQuest
was founded in October 1995 by former FDA investigators. Since that time, our
staff has grown to include additional former FDA personnel as well as
experienced technical, quality, and compliance experts from the regulated
industries. The officers and employees of
EduQuest
thus offer a comprehensive knowledge of FDA and
quality auditing procedures and practices and a unique awareness of regulatory
enforcement policies and activities. We believe that tremendous synergy comes
from having experienced, senior level personnel from both FDA and the industry.
Our combined experience also gives us a broad and detailed understanding of the
complex business and compliance challenges faced by today’s regulated
companies.
The
EduQuest
team is led by Martin Browning, the company’s
President and co-founder. Martin spent 22 years with FDA as a local, national,
and international expert investigator, and then as a Special Assistant to the
Associate Commissioner for Regulatory Affairs. While with FDA, he also served
as the Vice Chair of the agency’s Electronic Record and Signature Working Group,
which drafted the 21 CFR Part 11 regulations. Martin also served as the Chair
of the U.S. Government ISO-9000 Committee; on the Global Harmonization Task
Force; and on the committee that developed the Good Manufacturing Practice
regulations for medical devices, otherwise known as the Quality System
Regulation (QSR).
The relatively brief history of
EduQuest,
however, does not fully reflect our extensive experience in addressing
regulatory compliance, validation, and related technical issues. During their
careers at FDA,
EduQuest
personnel –
-
Participated in developing
many of the enforcement policies and inspectional procedures currently used by the agency;
-
Developed and presented the
training courses that FDA uses to train investigators in GMPs, computerized
system validation, process validation, and auditing; and
-
Conducted, supervised, and/or
coordinated thousands of FDA inspections and audits involving FDA-regulated
industries at every stage of research, development, and marketing.
Many of the FDA inspections
performed by our personnel involved findings of substantial violations and
resulted in further administrative and legal enforcement actions by the U.S.
government, including injunctions, product seizures, and criminal prosecutions.
This inspectional experience gives us first-hand knowledge of some of the best
and worst compliance efforts across the regulated industries, as well as the
practical risks and consequences of non-compliance.
It
is important to recognize that our staff includes more than former FDA
investigators and reviewers. Several of our employees have decades of
experience in achieving or assessing compliance as career industry
professionals, with expertise in quality, compliance, manufacturing, clinical
research, regulatory enforcement, adverse event reporting, validation, and
software development. This gives us the ability to provide our clients the
combined expertise of knowledgeable professionals who have directly experienced
both sides of the regulatory compliance and enforcement environment.
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