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Date : Wednesday, July 20, 2011 Time : 10:00 AM PDT | 01:00 PM EDT Duration : 60 Minutes Price : $245.00

Live Webinar ISO 13485 as a Quality Management System for Medical Devices  

  Overview: This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485:2003 will find themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. Areas Covered in the Session: l l l l l l

Principles of ISO 13485:2003 ISO 9001 & ISO 13485 Differences Design Control Risk Management & ISO 14971 MDD 93/42/EEC & Essential Requirements FDA’s MDR’s & EU Vigilance

Click here to register for this webinar Who Will Benefit: l l l l l

Regulatory Professionals Quality Engineers Manufacturing Engineers Operations Executives QA Managers

 

 

Register Now  Instructor Profile: John Chapman Regulatory Affairs Professional

John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has   been performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference. ...more

 

 Related Products ISO 13485 Gap Analysis Toolkit

 

ISO 13485 Quality Manual

 

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Your Necessity is our Priority

 

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or


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ISO 13485 as a Quality ManagementSystem for Medical Devices  

This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and F...

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