Former FDA investigators, rule-makers,
and senior executives from regulated industry.
Sought-after industry advisors since 1995.
Martin is the
President and co-founder of
He has over 35 years of experience at the U.S. Food and Drug Administration and
industries regulated by the FDA. He offers EduQuest clients extensive expertise in FDA
compliance, Part 11 and Annex 11 interpretation and compliance, quality
systems, software and systems engineering, inspection preparedness, and
auditing of internal systems and suppliers. His specific experience
also includes quality systems design and documentation, verification and validation of production
processes and software, and responding to FDA enforcement actions. Martin is a well-known expert in FDA regulations,
having written or contributed to writing many during his FDA career. He left
FDA in 1995 after serving 22 years as a local, national,
and international expert Investigator and then as a Special Assistant to the
Associate Commissioner for Regulatory Affairs in FDA headquarters.
While at FDA, Martin served as
Vice Chair of the Electronic Record and Signature Working Group, which drafted
the 21 CFR Part 11 regulations. He also served as Chair of the U.S. Government
ISO-9000 committee; on the Global Harmonization Task Force; and on the committee
that developed the medical device good manufacturing practice regulations,
otherwise known as the Quality System Regulation (QSR). He helped to
develop and lead the
Validation training courses originally presented to FDA and now offered
regularly for pharmaceutical, medical device, biotechnology, food and
tobacco companies around the world.
Martin has an undergraduate
degree in Aerospace Engineering and Political Science and a Masters degree in
Sharon A. Strause
Sharon is a national authority on computer
systems validation and a member of EduQuest's global consulting and training
team. She has more than 20 years of experience in the pharmaceutical and medical
device fields, including 15 years at McNeil Consumer & Specialty
Pharmaceuticals, a Johnson & Johnson Company.
For seven of those years, Sharon
managed the Quality Sciences and Compliance Document Control Group that
established standards, policies and practices for documentation. She also was
responsible for computer system validation on the McNeil/JJMCP SAP project.
Sharon is a member of the advisory board of the Institute of Validation
Sharon has been the editor of the Computer Validation Forum
published in the Journal of Validation Technology. She received an Industry
Recognition Award from IVT in 2004.