Speakers

Our speakers for the Quality Systems Educational Forum on Production and Process Controls included, in strict alphabetical order:

	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.
	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.
	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.
	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.
	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.
	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.
	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.
	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.
	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.
	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.
	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.
	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.