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MasterControl Inc. will present "Change Control--a Risk-Based Approach" as a workshop at the MD&M Texas 2012 Conference, March 15, 2012, at the Fort Worth Convention Center in Fort Worth, Texas. MasterControl's Kevin Marcus, product manager and medical device expert, and Walt Murray, director of quality and compliance services, will conduct the workshop.
The workshop will cover the principles of change control, using a risk-based approach. Attendees will learn to avoid reactive change control. An advanced quality planning model will be used to show the cyclical loops necessary for a closed methodology. The method will encompass a typical product lifecycle from supplier controls to post-market feedback (surveillance).
Two case study applications will be used to present an unplanned (reactive) and planned (proactive) context for thorough gateway change control. Considerations for criticality and complexity will be included in the analysis of the cases and how to escalate process and team involvement based on level of risk.
Regulatory guidance regarding key aspects of a device will be discussed with consideration of effects due to cumulative change.
The workshop is designed for employees of the medical device industry whose expertise lies in research and development, product development, general and corporate management, manufacturing, and quality.
Kevin Marcus is a quality systems professional with more than 25 years' experience in the medical device and pharmaceutical industries. His experience includes the understanding, development and maintenance of quality systems to ensure regulatory compliance, including FDA cGMP/QSR; ISO-13485:2003; European Medical Device Directives (MDD); and the Canadian CMDR. His professional experience includes serving as director of quality at Edwards Lifesciences, VP of quality at Research Medical, Inc.; product compliant manager at Pfizer Hospital Products Group; and quality assurance positions with Dow Corning Opthalmics and Alcon Optics. Marcus has extensive auditing background with an emphasis on developing and administering quality systems compliant to ISO-9000, ISO-13485, MDD, CMDR and FDA device and drug regulations, and cGMP/QSR, as evidenced by internal and external audit results. His bachelor's degree is from California State University at Long Beach and he is a senior member of ASQ and a past board member of the Intermountain Biomedical Association.
Walt Murray is a specialist in the quality and regulatory professions with more than 25 years' experience to his credit, working with nationally recognized organizations including Aventis- Pasteur, Merck, Pfizer, Stryker, USANA, Del Monte Foods and the American Red Cross National Labs. He is certified in quality systems auditing, problem solving, and process control using Six Sigma principles that support lean enterprise, including kaizen improvement and advanced planning principles. His extensive audit experience covers several industries and he's successfully brought several medical device companies to full registration under the ISO process model standard. Murray has also worked extensively in risk and supplier management. A graduate of the University of Richmond, Murray is a member of the Society for Manufacturing Engineers (SME); Regulatory Affairs Professions (RAPS); the American Society for Quality (ASQ); and the Intermountain Biomedical Association (IBA).
For more information about MD&M Texas, visit http://www.canontradeshows.com/expo/texas12/conference.html.
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