HOLMDEL, N.J., Feb. 9 /PRNewswire/ --
WHAT: Sparta Systems, Inc., the maker of TrackWise(R) and the market leader in enterprise quality and compliance management software, is pleased to announce its forthcoming webinar: "Regulatory Reporting for the Medical Device Industry (eMDR)," a free Webinar scheduled to "go live" on Tuesday, Feb. 10, 2009 at 2:00 p.m. EST. Due to the overwhelming volume of paper-based MedWatch 3500A reports received by the FDA's Center for Devices and Radiological Health (CDRH) in recent years, the agency has developed guidance for electronic reporting submissions. This Webinar will provide an overview of the status of eMDR applications and provide medical device manufacturers with a step-by-step approach to implementing a Quality Management Solution to automatically produce compliant electronic reports for submission to the FDA. By effectively executing the steps provided -- which include both Greenfield and Incremental approaches -- organizations of all sizes can realize significant cost benefits and proactive compliance with FDA regulations that will ultimately result from eMDR. WHO: "Regulatory Reporting for the Electronic Medical Device (eMDR) Industry" will feature live presentations by Sparta Systems experts who have extensive experience in the fields of software device reporting and device regulatory practices. Participants in the Webcast include: Mike Jovanis, Vice President, Product Management Mike Jovanis leads the collaborative effort of defining and implementing product strategy for Sparta Systems' flagship TrackWise(R) Enterprise Quality Management software. He is a thought leader in the fields of quality systems, regulatory compliance and the implementation of enterprise software across the life sciences industry. Joby George, Product Manager Joby George is a recognized expert on the topic of medical device reporting, and has worked in close communication with the FDA to determine specific requirements of eMDR submission to the CDRH. WHEN: Tuesday, Feb. 10, 2009 2:00 p.m. EST 1:00 p.m. CST 11:00 a.m. PST
About Sparta Systems:
Sparta Systems, Inc. is the industry leader for global quality and compliance management systems. Its TrackWise(R) product is a Web-based enterprise software application used by quality, manufacturing, regulatory affairs and business professionals to manage quality, compliance issues and action items across the enterprise. The company has more than 14 years of experience and an extensive customer base in the life sciences and other highly regulated industries. Sparta Systems offers its customers a complete solution for global quality management needs, including the onsite support required throughout the project lifecycle. More information about Sparta Systems and TrackWise(R) products can be found at www.sparta-systems.com.
Press Contact: Katy Zack Articulate Communications Inc. 212.255.0080, ext. 11 firstname.lastname@example.org
|SOURCE Sparta Systems, Inc.|
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