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Lora Keena to address Root Cause Package Failure Analysis at MD&M East, June, 2008
Grand Rapids, Michigan, USA...Lora Keena, Oliver Medical director of QA/RA, has been invited to address the 2008 Medical Design & Manufacturing (MD&M) East conference in New York City. Keena's presentation was well received at MD&M West in January, prompting conference organizers to invite her to speak again at MD&M East.
Keena will speak on the topic "Root Cause Package Failure Analysis" during the medical packaging conference session (#102) on June 2. The presentation will provide audience members with a guide to analyzing package failure, including a discussion of fishbone analysis (including the "6 Ms") and 'five-why' root cause analysis. Keena will also cover many anomalies that may result in seal failure, providing case studies and several specific examples of seal defects. Audience members will have a chance to ask questions after the presentation.
Oliver Medical's technical director, Randy Troutman, will chair the medical packaging conference session, which will focus on ISO 11607 compliance and will feature an interactive approach.
Lora Keena is Oliver Medical's director of QA/RA and is responsible for initial FDA and ISO registration, inspection, and compliance for US and European facilities. Lora's areas of expertise include international auditing; quality systems; and supplier, product, and process validation. Lora was previously director of QA/RA at LMI Medical, which was subsequently purchased by Tyco.
For more information, contact:
Jeff Murak
director of marketing & sales
616.456.7711 x7476
jmurak@olivermedical.com
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