Date :
Place : United States, San diego, ca
Contact Person:Eevnt Manager
Description:
Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2016 emphasizes this problem. Manufacturers must identify their roles, identify the regulatory requirements for that role, and incorporate them into the quality management system. The various jurisdictions, however, deal with post-market device issues in many different ways. The quality management system, QMS, needs three interlocking process: complaint management, adverse event reporting, and recalls. These processes also have supporting QMS processes such as corrective action and design changes. Overarching the QMS processes are the regulatory requirements, usually involving record keepingDeadline for abstracts/proposals : 24th October 2017
Organized By :NetZealous DBA as GlobalCompliancePanel
Keynote Speakers : Dan O'Leary President, Ombu Enterprises Dan O'Leary is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Audit
Conference Highlights :Quality Directors and Managers Regulatory Directors and Managers Design Engineering Managers Sustaining Engineering Managers Risk Managers Complaint Specialists Adverse Event Reporters Corrective Action Specialists Recall Specialists
Venue :San Diego, CA, United States
Check the event website for more details.