Tampa, FL – November 13, 2009 -- Pilgrim Software, Inc. a world-leading provider of Enterprise Compliance and Quality Management (ECQM) software solutions, today announced that Deb Kacera, Senior Product Manager, Regulatory Products, for Pilgrim, addressed an audience of medical device manufacturers at the Medical Technology Learning Institute’s (MTLI) 2009 regulatory workshop on MDRs, eMDRs, and Global Adverse Event Reporting, Nov. 9-10 in Washington, D.C. The conference covered current practical and policy issues in US and international adverse event reporting.
Indira Konduri, CDRH eSubmissions Program Manager with the Office of Surveillance & Biometrics at CDRH, presented an overview of electronic medical device reporting, the current status, and outlined the possible solutions available for manufacturers/importers to become compliant to the eMDR pending regulation.
Kacera offered her experience in the Industry Panel discussion that followed on choosing the appropriate pathway for high-volume and low-volume reporters, resource allocation, frequently asked questions and implementation challenges, cross-functional collaboration requirements between regulatory and IT, and debugging an eMDR system.
“The FDA is going electronic, and while the agency has not yet announced when eMDR will be mandatory, the number of manufacturer’s who are live and in the process of going live with their own electronic reporting programs continues to increase,” Kacera said. “But it’s a long process and there are many companies that are just now starting to get educated on what eMDR is and what their options are for being able to meet this requirement.”
The FDA has recommended that the requirement to make eMDR mandatory take affect one year from the date of the Final Rule; however, Industry can submit comments on the Proposed Rule until November 19, 2009 at www.regulations.gov. The FDA wants to see this happen as soon as possible Kacera stated, so they can start to reap the benefits of electronic transfer of information.
“It’s important that manufacturers recognize the FDA is just at the beginning of the electronic implementation curve, so look to more of the FDA forms and processes becoming electronic in the years ahead,” she said. “The more quickly medical device companies get on board, the sooner they will be able to leverage the resulting cost savings, timeliness of data sharing and increased accuracy of information.”
In the past two years, Kacera has worked closely with the FDA to contribute her expertise and insights to planning and development of the new CDRH eMDR program and Pilgrim’s new eMDR functionality. She has been involved with the FDA during the roll out of the enhanced CDRH “Event Codes.” As a leading subject matter expert in eMDR technology, she is frequently invited to speak on eMDR at numerous prestigious conferences and seminars in both the U.S. and Europe.
Kacera was named one of the “100 Notable People” in the medical device industry in 2008 by MD&DI magazine. As Senior Product Manager at Pilgrim Software, she is responsible for the company’s CAPA and Complaints management software products. She determines specifications for product enhancements, new products and third-party product integration. She supports Pilgrim’s products through all stages of their lifecycles, including conception, definition, development, release and post-release activities. She works closely with customers, associations and regulatory bodies, including the FDA and European Competent Authorities, to generate requirements for future products and enhancements.
MTLI offers a variety of educational programs including regulatory, technical, and professional training courses covering all facets of the medical technology business lifecycle. Faculty are drawn predominantly from AdvaMed member companies and government, complemented by a cadre of industry thought leaders. www.advamedmtli.org
About Pilgrim Software, Inc.
Pilgrim Software, Inc. is a world-leading provider of Enterprise Compliance and Quality Management solutions for global organizations. Named 2007 & 2008 North American Enterprise Compliance & Quality Management Company of the Year by Frost & Sullivan, Pilgrim helps organizations manage industry and regulatory compliance, reduce manufacturing costs and improve customer satisfaction. For more information, visit Pilgrim’s website at www.pilgrimsoftware.com.