Documenting Key Quality and Regulatory Processes
30 April 2010
7:45am–4:30pm
Crowne Plaza Mid-Peninsula
Foster City, CA 94404
Join your quality and regulatory colleagues from the ASQ Biomedical Discussion Group and the RAPS San Francisco Bay Area Chapter for a lively and informative one-day workshop on documenting key quality and regulatory processes. Experts use a mythical medical device to demonstrate by example how to prepare key documentation in the following areas:
• Risk Management
• Corrective and Preventive Actions (CAPA)
• Usability Engineering
• Essential Requirements
• Technical Files
Quality, regulatory and other industry professionals currently working in these areas will leave the program with an expanded and practical understanding of document preparation.
Speakers:
Grace Bartoo, PhD, RAC, CQA, has worked in medical devices since 1981, starting as an R&D engineer. She moved into clinical, regulatory and quality in the late 1980’s as she took her first start up company, NeoPath, from concept to commercialization. Bartoo has run a medical device consulting company for the past 10 years where she has helped numerous companies, has served on the Adcom Board for IEEE EMBS, and served on FDA’s General and Plastic Surgery Devices Panel.
Paul Brooks is the vice president, healthcare solutions for BSI and leads BSI services for the healthcare sector in North America. He qualified as a technician-engineer at BSI Testing Laboratories and was head of notified body for BSI’s Medical Devices Group from 1998 to 2002. Today, Brooks is located in BSI’s Washington, DC, office, responsible for leading BSI activities in the medical devices sector including the Notified Body for CE Marking and interfacing with US FDA and Health Canada. Brooks is a long-standing member of the American Society for Quality Biomedical Division and a member of the Regulatory Affairs Professionals Society (RAPS) board of directors.
Barry Craner, MS, MBA, RAC, CQE, CRE, CQA, CBA, is director of design assurance for Boston Scientific Corporation, past chair of the ASQ Biomedical Division, past chair of the ASQ Biomedical Northern California Discussion Group, and an assistant professor at California State University, Dominguez Hills and Instructor for UC Santa Cruz Extension, teaching risk management. He has delivered numerous papers and presentations on topics such as calibration systems, management auditing, software quality assurance, design control, managing contract design and issues in virtual/startup companies. Craner was on the founding team to create the body of knowledge and examination questions for the new ASQ CQA-Biomedical Auditor certification program, and was awarded the Simon Collier Quality Award by Los Angeles ASQ Section in 2008.
Connie Hoy has worked in the medical device industry for 25 years. She began her career as the original employee of a start-up company that made Class III sterile implantable devices, and brought this company from concept to a commercial product. She later transitioned into the medical laser industry where she spent 13 years. Most recently she made another transition to XOFT, Inc, a manufacturer of innovative cancer therapy devices where she is the vice president of regulatory affairs and quality assurance. Hoy has authored more than 100 510(k) submissions, including the first laser to ever be cleared for sales as a home use device. She has also worked extensively in international regulatory, where she has obtained multiple CE Marks as well as Rest of World approvals. Hoy holds an MA from the University of New Mexico.
Mark Perkins began his career in aerospace and later transitioned into medical devices. He held management positions in quality assurance and regulatory with Class I, II and III medical device companies prior to establishing his consulting practice in 2008. Perkins is a registered Professional Engineer in the state of California, is RAC (US) certified through RAPS, and is ASQ Certified (CQE, CQM, and CQA). He holds a BSIE from Texas A&M University, is currently enrolled in the MSRA program at San Diego State University, and has an Advanced Certificate in Regulatory Affairs from San Diego State University
Note: In order for ASQ Members to register at the member rate, it is necessary to submit your registration using the registration form.
Link to Event site and Registration: http://www.raps.org/PersonifyEbusiness/tabid/1615/Default.aspx
Local Contacts:
RAPS San Francisco Chapter Contact:
Michelle Ragozzino, PhD, director of bioscience programs, UCSC Extension, +1 408 861 3861
American Society for Quaility Contact:
Walter Crompton, +1 415 484 1688
