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Meet
the
EduQuest Staff:
Former FDA investigators, rule-makers, office directors,
and senior executives from regulated industry.
Sought-after industry advisors for more than 15 years.
 Martin Browning
– Martin is the
President and co-founder of
EduQuest.
He has over thirty years of FDA and regulatory experience. He has and
demonstrates extensive expertise in management consulting, FDA regulation,
regulatory affairs, quality assurance, software and systems engineering, and
auditing. Specific experience includes quality systems design, system design
assurance, verification and validation of production and medical systems,
processes and software. Martin is a well-known expert in FDA regulations
having written or contributed to writing many during his FDA career. He left
the Food and Drug Administration in 1995 after 22 years as a local, national,
and international expert Investigator and then as a Special Assistant to the
Associate Commissioner for Regulatory Affairs.
While with 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 new medical device good manufacturing practice regulations,
otherwise known as the Quality System Regulation (QSR). He helped to
develop and lead the
EduQuest
Computer System
Validation training courses presented to FDA. Martin has an undergraduate
degree in Aerospace Engineering and Political Science and a Masters degree in
Computer Science.
 Gordon B. Richman – Gordon is the Vice
President of Strategic Compliance Consulting and General Counsel of
EduQuest.
He joined the company in January 2002. Gordon brings a
unique background and over 20 years of regulatory, legal, and corporate
management experience to
EduQuest, including more than 10 years in increasingly
responsible senior management positions with leading pharmaceutical and medical
device companies, first as Director of Worldwide Quality Strategy in
GlaxoSmithKline’s Global Manufacturing and Supply operations, and then as Vice
President of Regulatory Compliance at Fisher & Paykel Healthcare and Vice
President of Regulatory Affairs at Masimo Corporation. Previously, he
spent several years in FDA regulatory practice with major law firms in
Washington, D.C., where he advised and defended pharmaceutical and medical
device companies on a broad range of FDA regulatory issues, including both
administrative and criminal enforcement matters.
Gordon has
a broad base of experience in the complex, cross-functional issues faced by the
FDA-regulated industries, including matters that span across Manufacturing and
Supply (e.g., good manufacturing practices, internal auditing, product
complaints and failure investigations, field alerts and recalls, process
validation, change control, inspectional preparedness and responses, and
regulatory enforcement); Research and Development (e.g., good clinical
practices, good laboratory practices, adverse event reporting, medical device
design, clinical data management, drug and medical device labeling, clinical
protocol design, informed consent, toxicity assessments for child-resistant
packaging, the inclusion of women of child-bearing potential in clinical trials,
and FDA inter-center jurisdiction for combination products); and Information
Technology (e.g., computer systems quality, compliance, and validation, software
development, and compliance with regulatory requirements for electronic records
and electronic signatures). He also has extensive experience
in developing and providing training on FDA’s good practice requirements,
regulatory compliance, and inspectional preparedness. Gordon has a Bachelor of Science in Chemical Engineering (with a
specialization in chemical process control) and a Juris Doctor degree.
 Denise D. Dion
– Denise
is a Vice President for Regulatory and Quality Services for
EduQuest
and has been with the company since December 2002. She left the Food and Drug
Administration in 2002 after 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 and training materials. She served on FDA’s Design Control
Inspection Strategy Team, was the editor of the Investigations Operations Manual
for five years, and participated in FDA’s basic medical device and process
validation training.
Denise
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. Denise 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, clinical investigators, 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.
 Janis V. Olson –
Jan is a Vice President of Regulatory and Quality Services for
EduQuest
and has been with the company since December 2000. Prior to that she worked for the U.S. Food and Drug Administration for over 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) in 1998/99, including the satellite downlink in
1999. She has given numerous presentations to industry on GxP, computer
system validation, and Part 11.
Janis 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).
Clarence G. Danielson – Clarence "Danny" Danielson is
the Director of Client Services for EduQuest and has been with the
company since 1998. He left the Food and Drug Administration in 1997 after
25 years as an Investigator, Supervisory Investigator, and then as the Director
of the Investigations Branch in Nashville. He served on a number of
Headquarters committees including the DIB Field Advisory Committee and the
Biologics Field Advisory Committee. He was an instructor at the Law and
Evidence Development Courses and various Blood Bank Courses. He
participated in all of the EduQuest Computer System Validation training courses
presented to FDA. Danny has a Bachelor of Science in
Biology.
Martin L. Heavner – Martin is the Director of Marketing and New Products for EduQuest. He has been working with regulated
industry in the U.S. and overseas for more than 30 years. He has developed
curricula for more than 220 industry training courses delivered both in
classroom settings and through self-study programs, e-learning technologies and
multi-media webinars. He has special expertise in working with Subject Matter
Experts (SMEs) to educate adults about complex regulatory requirements and
develop practical training materials that help them cost-effectively comply with
FDA, EPA and OSHA rules.
At EduQuest,
he manages corporate communications, develops new information products, assists
the delivery of the company’s open enrollment and private courses, and oversees
more than 70 online FDA, ICH, and EMEA compliance courses developed by EduQuest
for Kaplan/EduNeering’s ComplianceWire, an integrated learning management system
used by hundreds of biopharmaceutical and medical device companies worldwide. In
addition, Martin coordinates the Quality Compliance Coach (QCC), an annual
subscription service developed jointly by EduQuest and Kaplan/EduNeering to
reinforce quality as an integral aspect of a company’s culture. He is the
founding editor of Hazardous and Solid Waste Minimization News, the Energy
Reference Handbook, the FDA Regulatory Reference Library, and a series of
“Strategies for Winning at the FDA” compliance handbooks. He has written or
co-authored more than 20 trade journal articles. Martin has an MBA from
Frostburg State University with a concentration in business and technical
writing and a Bachelor of Science in Journalism from West Virginia University.
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