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SALT LAKE CITY, USA - March 5, 2012 - MasterControl, Inc., a global provider of quality, audit, and document management software solutions, today announced that two of its experts will speak at Medical Design & Manufacturing (MD&M) Texas, March 14-15, 2012 at the Fort Worth Convention Center.
Kevin Marcus and Walt Murray will present an afternoon workshop entitled "Change Control – a Risk-Based Approach." Marcus is MasterControl's product manager/medical device expert and Murray is the company's director of quality and compliance services. The workshop will address change control using a risk-based process model approach. Two case study applications will be used to present an unplanned (reactive) and planned (proactive) context for thorough gateway change control.
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.
Murray is a specialist in the quality and regulatory professions with more than 25 years’ experience to his credit, working with nationally-recognized companies. 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.
About MD&M TexasMD&M Texas is a new launch in 2012 by the industry leading Medical Design and Manufacturing conference and exposition series, bringing the high standard of engaging, relevant content to the expanding medical device market in Texas. The MD&M series has been covering key issues in the medtech hubs annually in the West (Anaheim, CA), East (Philadelphia, PA) and Central (Minneapolis, MN) areas in the United States as well as designing specialized local events in San Jose, CA and Boston, MA under the BIOMEDevice brand. The conference will be running alongside the MD&M Texas expo, a showcase of more than 514 exhibits of the latest technology and equipment. MD&M Texas attendees will also have full access to the co-located Quality Expo, Automation Technology Expo (ATX), TexasPack, Design and Manufacturing, AeroCon, Sustainability in Manufacturing, and Contract Manufacturing Expo.
About MasterControlMasterControl Inc. produces software solutions that enable companies doing business in regulatory environments to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company's critical information throughout the entire product lifecycle. MasterControl software is known for being easy to implement, easy to validate and easy to use. MasterControl solutions include clinical management, quality management, document management/document control, product lifecycle management, audit management, training management, bill of materials, supplier management, submissions management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl provides our customers with a complete information management solution across the entire enterprise. For more information about MasterControl, visit www.mastercontrol.com, or call: 800-825-9117 (U.S.); +44 (0) 1256 325 949 (Europe); or 81 (3) 5422 6665 (Japan).