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The following are the speakers for the FMDIC Risk ,
CAPA, and Training Educational Forum.
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David Arvelo is the Small Business Representative
for the Southwest Region of the Food and Drug Administration. He has a
Bachelors of Science in Chemistry from the University of Puerto Rico and graduate studies
in analytical chemistry and toxicology from
Texas A&M University. He worked for the Office of the Texas State Chemist
for 2 years prior to working for the FDA. He started his FDA career in 1990
as a Chemist in the Dallas District Laboratory. |
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David K. Glasgow is
employed by the Food and Drug Administration, Office of Regulatory Affairs,
Dallas District Office and is the Director, Investigations Branch. David has
been with FDA for 19 years as an investigator, supervisor and now branch
director. David has worked in five different FDA districts across the
country and ORA Head Quarters in the Office of Enforcement. David's
inspectional background is in all program areas with an emphasis in medical
device manufacturers and bioresearch monitoring. |
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Lori Holder is a Senior
Manager of Regulatory Affairs at Alcon Laboratories, Inc., a leading
manufacturer of ophthalmic medical devices and pharmaceuticals located in
Fort Worth Texas. She has over 15 years of experience in the medical device
industry and has held positions in clinical research, quality assurance, and
regulatory affairs. Lori holds certifications in Regulatory Affairs and
Quality Management and has a B.S. in Biomedical Engineering from Texas A&M
University. |
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William A. Hyman, Ph.D., is a
professor of biomedical engineering at Texas A&M University (TAMU, College
Station, TX). He holds an ScD in engineering mechanics and an MS in
engineering mechanics from Columbia University, and a BSME in mechanical
engineering from The Cooper Union. His primary area of professional activity
is in medical device design, system safety and human factors. He has served
as a consultant for FDA, the National Science Foundation, the National
Institutes of Health, the U.S. Army, the General Accounting Office, for
medical device companies, and in patent and personal injury litigation. He
holds memberships in the American Society for Testing and Materials (ASTM),
the American College of Clinical Engineering, the Association for the
Advancement of Medical Instrumentation, the Biomedical Engineering Society,
and the Human Factors and Ergonomics Society technical group on medical
systems and functionally impaired populations. Hyman serves on the ASTM
committees on surgical implants and medical devices and is a board member of
the U.S. Board of Examiners for Clinical Engineering, and of the ACCE
Healthcare Technology Foundation. He is a member of the Dallas District
FDA/Industry Coalition, and is an editor of the Journal of Clinical
Engineering. Dr. Hyman is a registered professional engineer in Texas. |
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Philip G. Ralston, Jr.,
has 30 years in the life science industry as a senior executive, inventor,
company founder, venture capitalist, and business coach. Phil received a
foundation in product development and technology commercialization at Baxter
Healthcare, as Director of Biomedical Engineering. Phil started four
companies, has been the senior operating executive of two mid-size medical
device companies, and has been a business coach for several Fortune 500,
mid-size, and start-up clients. Phil has a Master of Business Administration
from the Kellogg School of Management at Northwestern University, and a
Bachelor of Science Degree in Chemistry from Brigham Young University. He is
a charter board member of the Medical Device Manufacturers Association and
currently serves on the advisory board of the Houston Technology Center,
Medici Biomedical Development Center, Executive Committee of the Center for
New Ventures and Entrepreneurship at Texas A&M University, and the Greater
Houston Partnership Emerging Business Council Executive Committee. He
teaches a senior-level class on Small Business Growth and Management at the
Mays School of Business at Texas A&M University in College Station, Texas.
He is currently the principal of The Ralston Group, a business coaching
firm, and an associate with Amica Solutions, a regulatory and quality
systems consulting firm. |
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Rebecca Rickey is Vice
President of Quality Assurance (North America) for Sterigenics,
International, the world’s leading provider of contract sterilization
services offering gamma, electron beam, and EO processing for the medical
device, pharmaceutical, and food industries. Rebecca has over 25 years
experience in quality management in the pharmaceutical and medical device
industry. She is a member of AAMI and has served on AAMI/ISO/TC 198 WG 1,
Ethylene Oxide Sterilization Working Group and AAMI/ISO/TC WG2, Radiation
Sterilization Working Group, and is currently serving on AAMI/QM/01,
Application of quality systems to medical devices (the US contributor to
ISO13485:2003) and AAMI/QA/02, General Aspects stemming from the application
of quality principles to medical devices. Rebecca is a Senior Member of ASQ,
a Certified ISO 9000 Lead Assessor, and holds a BA degree from Oklahoma City
University. |
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Philip M. Steele, Ph.D.,
is employed by the Food and Drug Administration Office of Regulatory
Affairs, Dallas District Office/Investigation Branch, as a Consumer Safety
Officer. In the last four years, his primary areas of responsibilities
include the performance of inspections of medical device and pharmaceutical
manufacturers for the FDA Dallas District Office. He is a member of FDA
international inspections cadre. Philip holds a Ph.D. in Biomedical Science
from the University of Texas Health Science Center. He has over 15 years of
experience in laboratory practices in neurobiological electrophysiology,
chemistry, and microbiology. Philip has participated as an instructor and
lecturer at the University of Texas Medical School, the Universe of Texas
Graduate School for Biomedical Science, and at Rice University. |
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Monica Wilkins is employed by the FDA Office of
Regulatory Affairs, Division of Field Investigations, as a Medical Device
National Expert. Her current responsibilities include the performance of
both domestic and international inspections of medical device manufacturers,
instructing at the FDA National Courses, and assisting in the review of
policies and guidance documents. In her previous positions, she was
a Compliance Officer (CO) for the Dallas District Office. As part of her
duties as a CO, Monica continued to perform domestic and international
inspections of medical device manufacturers. Prior to becoming a CO, she was
the Medical Device Specialist for the Dallas District Office and a member of
the International Inspections Cadre. As a Medical Device Specialist, she
primarily performed domestic and international inspections of medical device
manufacturers. She has 11 years of experience in performing medical
device and pharmaceutical inspections.
During her employment with FDA, Monica has participated as an
instructor for numerous courses such as the AAMI Design Control Requirements
and Industry Practice Course, AAMI Process Validation Requirements and
Industry Practice Course, FDA Reprocessing of Single-Use Devices, FDA Basic
Medical Device Course, FDA Process Validation Course, FDA Computer Systems
Validation Course, FDA Computer Aided Inspections Course AFDO-Industrial
Sterilization Workshop, and Dallas District local training courses.
Prior to her employment with FDA, her career included employment in the
regulatory, computer, healthcare, and pharmaceutical industries. Monica
has held the positions of Research Assistant, Quality Control Technician,
Microbiologist, Supervisor, Manager, Specialist, Director, and Consultant.
She holds a Bachelors degree in Microbiology from the University of Texas at
Austin. |
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