The Food and Drug Administration has issued more than 50 warning letters to medical device companies for insufficient corrective and preventive action (CAPA) procedures. Large companies (e.g., Medtronic, Abbot, GE) as well as some of the smallest companies have not been spared.
In a new Medical Device Daily audio conference, speaker Sue Jacobs, principal consultant at QMS Consulting Inc., will share her expertise in FDA compliance with medical device quality and regulatory requirements. She has more than 20 years of experience in the industry, assisting manufacturers and suppliers in implementing and maintaining compliant quality system programs.
"Avoid FDA Warning Letters With Strong CAPA Program" is just $349 per listening site. Scheduled for April 1, 2008 from 1–2:30 p.m., it includes presentation handouts and a half–hour Q&A session with the speaker. A conference CD (MP3 format) is also available. For more information or to register, call 800–688–2421 or 404–262–5474. Please mention conference code T08488.