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Instructors
Martin Browning
–
Mr. Browning 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 experiences include quality systems design, system design
assurance, verification and validation of production and medical systems,
processes and software. Mr. Browning 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 participated in the
EduQuest
Computer System
Validation training courses presented to FDA. Mr. Browning has an undergraduate
degree in Aerospace Engineering and Political Science and a Masters Degree in
Computer Science.
Thomas A. Boone – Mr. Boone is a
Senior Quality Systems Engineer and Validation Specialist for
EduQuest. He joined the company in December
1999, following his most recent position as Owner and President of Boone
Interactive, where he traveled nationally and internationally providing process
and product validation expertise as well as performing internal audits, medical
device submissions, and regulatory affairs management to small medical device
firms. Previously he spent many years working in the medical device industry
performing regulatory submissions, software quality assurance activities,
product and process validations, internal audits, training, writing policy and
procedures, and conducting reliability engineering studies. Mr. Boone has
a broad base of practical, hands-on experience across the entire GxP compliance
spectrum with emphasis on integration of computerized systems in the regulated
environment such as – Medical Devices (including MRP systems, complaint handling
software, failure investigation software, label management and tracking
software, calibration management software, LIMS systems, CAPA systems,
environmental monitoring systems, recall databases, blood bank software, medical
device validations with a computerized component), Pharmaceutical Manufacturing
(including HVAC systems, Environmental Monitoring Systems, Software for
monitoring Stability Studies, LIMS, computerized laboratory instrument
validations, annual reporting databases, adverse effects reporting systems),
Clinical Studies (including clinical trial databases, remote site data entry
software, clinical trial analytical and reporting systems), Radiological Health
(including radiation treatment planning computer systems, photon and electron
radiation delivery systems, gamma cameras, computerized axial tomography
systems, positron emission tomography systems, food and medical device
production irradiator computerized systems, Laser control systems, and dosimetry
software). Mr. Boone also has extensive experience developing and
providing training on FDA’s medical device regulations and guidance, finished
pharmaceutical regulations and guidance, good laboratory practice and guidance,
and regulatory compliance. Mr. Boone has a Bachelor of Science degree in
Electrical Engineering.
Denise D. Dion –
Ms. Dion is a Senior Regulatory Consultant 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. She 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).
Ms. Dion has a Bachelor of Science degree in Biology and Environmental Studies
and has completed post-graduate coursework in aquatic ecology, microbiology,
genetics, and biochemistry.
Janis V. Olson – Ms. Olson is a Senior Validation
Consultant 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. She is a member of the IEEE Computer Society. While with FDA, Ms. Olson
supervised the NDA/ANDA Approval Program for the FDA Atlanta District. She
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
January 1999. She has given numerous presentations to industry on GxP, computer
system validation, and Part 11. She has been involved in teaching computer
system validation to FDA personnel since 1991. She also 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). Ms. Olson has a Bachelor of Science Degree in Biology and a Master
of Science in Computer Systems (specialty in software engineering).
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