Tampa, FL – January 11, 2011 -- Pilgrim Software, Inc., a world-leading provider of Enterprise Risk, Compliance and Quality Management (ERCQM) software solutions, today announced that Deborah Kacera, Industry Solutions Director for Pilgrim, will join an exclusive panel discussion, “Complaints, MDRs, eMDRs: Practical Guidelines and Best Practices,” at Medical Device Summit’s dual conference event for Medical Device manufacturers, on February 22, 2011 in Orlando, FL. Kacera’s presentation will present best practices case studies and real-world examples of implementing an electronic medical device adverse event reporting (eMDR) program.
Per FDA guidelines Medical Device companies are required to establish complaint-handling procedures to detect, evaluate and appropriately address possible product-related problems. A complaint file is also a common starting point for FDA investigators assessing an establishment’s quality system. The practical challenges of establishing and maintaining a robust complaint-handling system can be daunting. During this conference, industry experts, faculty and FDA speakers will address practical challenges and enforcement trends through didactic sessions, interactive exercises, and discussions of pre-submitted questions.
Kacera’s presentation will provide attendees with a detailed look at how to implement a successful eMDR program, and a perspective on how the FDA is likely to inspect on these topics, and thus, how one should prepare for an inspection.
“Complaint handling is a vital process for medical device manufacturers in order to protect brand reputation, maintain regulatory compliance, and keep costs low,” Kacera said. “Presently, the FDA is completing final testing of its new data center and is on the verge of issuing a mandate requiring all manufacturers to submit information regarding these adverse events, electronically, through their eMDR initiative. So as part of the complaint handling process, it’s critical for all Medical Device companies to continue to work towards implementing their own electronic MDR reporting system.
The second conference of the joint Medical Device Summit event, FDA Inspections: Procedures and Best Practices for Medical Device Companies, is being held simultaneously, Feb. 22-24, 2011 at the Holiday Inn Downtown Disney, in Orlando, FL.
About Pilgrim Software, Inc.
Pilgrim Software, Inc. is a world-leading provider of Enterprise Risk, Compliance and Quality Management solutions for global organizations. Through its integrated platform, Pilgrim helps organizations manage industry and regulatory compliance, address potential risks, reduce manufacturing costs and improve customer satisfaction. Pilgrim has been named North American Enterprise Compliance & Quality Management Company of the Year – Best Practices by Frost & Sullivan, and winner of its 2010 North American Best-In-Class Customer Value Enhancement Award in the Enterprise Risk, Compliance and Quality Management Market for the Life Sciences Industry. For more information, visit Pilgrim Software’s website at www.pilgrimsoftware.com.
Nancy DeFilippis | Marketing Programs Manager (Events & Campaigns) | Pilgrim Software office: 813-915-1663 ext 2479 | fax: 813-915-1948 | www.pilgrimsoftware.com
