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Effective Hazard Analysis to meet FDA and ISO13485:2003 Risk Management Requirements - Webinar By GlobalCompliancePanel

 
  August 10, 2011  
     
 
global compliance panel, Online Training Webinar
2011-08-30


Why should you attend: Performing requires Hazard and Risk Analysis often poses a challenge for development teams. How detailed does the analysis have to be? What is the difference between hazard and harm, hazard and hazard cause, Hazard analysis and FMEA, etc.? How do we combine the risk rating when different mitigation measured are used simultaneously? This presentation will try to answer all these questions and provide a partial guidance on how to effectively perform a Hazard and Risk Analysis.

Areas Covered in the Session:
  • Structure of a Risk and Hazard Analysis document
  • Stakeholders and participants
  • How to conduct a hazard analysis meeting
  •  
  • Meeting ground rules
  • Hazard and Harm characteristics
  •  
  • Methods to identify potential hazards
  • Risk and Risk Rating methods
  • Risk mitigation strategies
  • Risk assessment and Residual Risk
Who Will Benefit:
  • Project Leaders
  • Design Engineers
  • Regulatory
  • Quality
 
 
Organized by: global compliance panel
Invited Speakers:
Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms.
 
Deadline for Abstracts: 2011-08-30
 
Registration:
 2011-08-30
 
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884
E-mail: webinars@globalcompliancepanel.com
 
   
 
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