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
Janis V. Olson
Jan is a Vice President of Regulatory and Quality Services for
and has been with the company since December 2000. Previously she worked for the
FDA for more than 22
years. While with FDA, Jan
supervised the NDA/ANDA Approval Program for the FDA Atlanta District. She
also conducted domestic and international inspections of FDA regulated industry,
including pharmaceutical, medical device, and biologics companies. She was also
part of the national FDA training for industry on Part 11 (Electronic
Signatures; Electronic Records. She has given hundreds of presentations to industry on
best practices GxP and Part 11 compliance, computer
system validation, and supplier management and auditing.
Jan has been involved in teaching computer
system validation to FDA personnel and industry specialists since 1991. She was a member of the PDA
committees that wrote Technical Report 32 (Auditing of Suppliers providing
Computer Products, October 1999) and GERM (Good Electronic Records Management,
July 2002). She is a member of the IEEE Computer Society.
Jan has a Bachelor of Science in Biology and a Master
of Science in Computer Systems (specialty in software engineering).
Denise D. Dion
is a Vice President for Regulatory and Quality Services for
and has been with the company since December 2002. Previously,
she was at the FDA for 18 years. During her last eight years with FDA,
she served in FDA headquarters as the medical device investigator liaison
between the Office of Regulatory Affairs (ORA) and the Center for Devices and
Radiological Health as well as between ORA headquarters and the field staff. She was one of the designers, authors, and trainers of the Quality System
Inspection Technique (QSIT). In addition, she served on FDA’s Design Control
Inspection Strategy Team, was the editor of the Investigations Operations Manual
(IOM)for five years, and participated in FDA’s medical device and process
was ORA’s final reviewer for on-line basic
investigator training courses and worked on the development of FDA’s Risk
Management and Computer System Validation on-line training courses. She has
performed expert-level inspections in the areas of medical devices, drugs, and
biologics. She has experience in regulatory requirements for foods, drugs,
devices, biologics, tobacco, clinical investigations, and institutional review boards (IRBs).
Denise has a Bachelor of Science in Biology and Environmental Studies
and has completed post-graduate coursework in aquatic ecology, microbiology,
genetics, and biochemistry.
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 is the editor of the Computer Validation Forum
published in the Journal of Validation Technology. She received an Industry
Recognition Award from IVT in 2004.