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Our speakers for the Quality Systems Educational Forum: Production and
Process Controls included, in alphabetical order:
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Margy Annes is a Consumer Safety Officer for the
FDA, located in the Dallas District Office, Oklahoma City Resident Post. She
has a BA degree in Biology from the University of Colorado in Boulder. She
began her career with FDA in 1997 in the Denver District Office, Salt Lake
City Resident Post, and transferred to her current post in September 2001.
Her primary responsibilities include conducting inspections of medical
device and pharmaceutical manufacturers. She is also a member of FDA's
Foreign Inspection Cadre, primarily conducting inspections of foreign
pharmaceutical manufacturers and clinical study sites. |
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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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Stan Bauman got his BS and
MS in microbiology at the University of Oklahoma, and his Ph.D. in
immunology and post-doctoral work in infectious diseases at West Virginia
University College of Medicine. He taught for 10 years at the University of
Kentucky College of Medicine, Department of Community Medicine. Stan started
his first medical device company in Kentucky in 1976 and his second in 1979
in Oklahoma. In 1994, he worked on the reform of the FDA regulatory process
for devices and formed the In Vitro Diagnostics Manufacturers Coalition. In
1996, Stan joined the board of directors of the Medical Device Manufacturers
Association. He is currently CEO of Immuno-Mycologics, Inc. and president
and CEO of QS-Solutions, Inc. |
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Cheryl Boyce has 17 years of regulatory experience
and is the former FDA Southwest Regional Medical Device Specialist where she
was involved in GMP precedent-setting court cases. She received three
commendable service awards while at the FDA. Cheryl has served as an master
expert witness for the FDA in the past. She has provided GMP and process
validation training to FDA and the Texas Department of Health as well as
many medical device companies. She has developed many systemic corrective
action plans for large and small companies and has performed 150 audits of
medical device, in-vitro diagnostic, GLP, pharmaceutical, and sterilization
facilities. She has also provided training at RAPS, ASQ, and AAMI seminars
on process validation, auditing, calibration, statistical techniques, and
packaging/labeling controls. Cheryl holds a B.S. degree in chemical
engineering and is Regulatory Affairs Certified, a Certified Quality
Auditor, and an RAB Certified Quality Systems Lead Auditor. She is a member
of RAPS, ASQ, and FMDIC. |
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Michael Chappell is a graduate of the University of
Alabama. He began his FDA career as a Consumer Safety Officer in the newly
created Nashville Section in Nashville, TN in 1972 when FDA’s principal
focus was foods and drugs. He has served as a Supervisory Consumer Safety
Officer in the Atlanta Office of the Atlanta District and then Director of
Investigations for the Florida District in Orlando. Mike is currently the
Dallas District Director with responsibility for all FDA domestic field
activities in the states of Texas, Oklahoma and Arkansas. He is a past
member and Chair of the Directors of Investigation committee for FDA field
investigations and is a current member and Chair of FDA’s Device Field
Committee. |
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Bruce Horowitz is Advanced Neuromodulation Systems'
Vice President of Product Assurance. He currently is responsible for
quality assurance and regulatory compliance. Before joining ANS, Bruce held various management positions including Director of Quality and
Regulatory Affairs for Quest Medical, Orthofix and Osteomed. He
has a bachelor's degree in biochemistry from Brooklyn College, City
University of New York. |
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Scott Nichols is a Supervisory Consumer Safety
Officer for the FDA Dallas District Office. He has a Bachelor of Science
degree in Nutrition from the University of Texas at Austin. He began his
career in Austin, TX as a medical device investigator for the Texas
Department of Health (TDH) in 1997. He became a program manager for the TDH
Drugs and Medical Devices Division in 2000. In 2001, Scott joined the FDA
Dallas District Office as a Consumer Safety Officer, with primary
responsibilities in conducting medical device manufacturer and clinical
bioresearch monitoring inspections. In addition, he is a member of FDA's
International Inspections Cadre. He became a Supervisory Consumer Safety
Officer in 2004. |
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Krista Oakes has 15 years of experience in quality
assurance, regulatory affairs, and executive management in the medical
device industry. Krista is currently the principal of her own company
providing compliance and training services for the medical device industry.
Prior positions include Director of QA/RA for Quest Medical, Vice President
of RA/QA for Epic Medical, President of Epic Medical, and Vice President -
Medical Device Division for Shotwell & Carr. She has developed and
implemented regulatory and quality systems strategies for both large and
small manufacturers. Krista is an ASQ Certified Quality Manager and an ISO
9000 Lead Assessor, and holds a B.S. degree in psychology from Brigham Young
University. She is active in the medical device industry with memberships in
RAPS, ASQ, AAMI, and FMDIC. She has been an industry speaker and author of
articles on practical and efficient approaches to quality systems. |
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Dan Olivier is an acknowledged expert in system
validation and safety risk management. He has supported over two hundred
companies in addressing regulatory issues and process improvement. Dan has
been contracted by FDA to provide training for field investigators, to
prepare inputs for FDA validation guidance documents, and represented ASQ in
meeting with the FDA to discuss implementation of Part 11. He is a ISO 9001
RAB certified lead auditor and has been a reviewer for ISO WG10 defining
software process assessment standards. A frequent speaker at professional
conferences and author of several seminars he has published over a dozen
articles on software validation, safety risk assessment, and design controls
to meet FDA and ISO requirements. His company provides validation
consulting, safety risk analysis, audits, training, development, and testing
services to meet the requirements of the FDA regulations and ISO 9001. |
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Cindy Walters has 17
years of experience in the medical device industry. She is currently Sr.
Quality Engineer responsible for Quality System Compliance at Medtronic
Powered Surgical Solutions and has held positions in Research and
Development, Product Evaluation, Quality Assurance and Control, and
Regulatory Affairs. Her background includes extensive experience in software
validations and packaging and sterilization processes. She has a B.S. degree
in Chemistry from Texas Wesleyan University. Cindy is a Certified ISO 9000
Lead Assessor and past ASQ Certified Quality Engineer. |
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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 eight 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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Norman Wong is an FDA National Expert in
Medical Devices. He has over twenty years of domestic and international
inspectional experience in medical devices. Norm is a principle instructor
in medical device, process validation, computer application and medical
device failure analysis agency courses. He has technical expertise in
medical device electronics, including microprocessor/computer based
circuitry, device and manufacturing process related software. |
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