Hazard Analysis vs. FMECA – Differences and Commonalities - Webinar By GlobalCompliancePanel by globalcompliancepane


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    RAPS Approved Webinar                 on
     Hazard Analysis vs. FMECA – Differences and Commonalities

    Date & Time:                                                                                                                 

     Course "Hazard Analysis vs. FMECA – Differences and
     Commonalities" has been pre-approved by RAPS as eligible for
                                                                                            Register Now                         

     up to 1.00 credits towards a participant's RAC recertification
     upon full completion.

                                                                                       Instructor Profile:

     Tuesday, August 14, 2012           10:00 AM PDT | 01:00 PM EDT
                                                                                                     Markus Weber
     Duration: 60 Minutes               Instructor: Markus Weber                              Principal Consultant, System
                                                                                                        Safety Inc.
     Location: Online                   Price : $245.00   (for one participant)

                                                                                       Markus Weber, Principal
                                                                                       Consultant with System Safety, Inc.,
    Overview:                                                                          specializes in safety engineering and
    The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and                risk management for critical medical
    Criticality Analysis (FMECA)" are often used synonymously. However,                devices. He graduated from Ruhr
    there are significant differences in both methodologies and their                  University in Bochum, Germany with
                                                                                       a MS in Electrical Engineering.
    strengths can be combined to ensure a safe and efficacious system
                                                                                       Before founding System Safety, Inc.,
                                                                                       he was a software safety engineer
                                                                                       for the German approval agency,
    The presentation will explain both methodologies and will show ways                TUV. Since 1991, Mr. Weber has
    how these tools can be used to complement each other. Additionally                 been a leading consultant to the
    the differences and limitations of both methods will be illustrated and            medical device industry on safety
                                                                                       and regulatory compliance issues,
    the appropriateness during the different product development
    phases will be discussed.                                                          specifically for active and software-
                                                                                       controlled devices. In conjunction
                                                                                       with the FDA, he has published
    Areas Covered in the Session:                                                      works on risk management issues
                                                                                       and software-related risk
                                                                                       mitigations. Mr. Weber has helped
       l   Hazard analysis techniques
                                                                                       multiple companies, from startups to
       l   FMECA techniques                                                            Fortune 500 firms. ...more
       l   Probabilistic approaches
       l   When to use which method during the design process
       l   Effective evaluation strategies and documentation formats
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    Click here to register for this webinar                                             Your Necessity is our Priority

    Who Will Benefit:

       l   Project Managers
       l   Regulatory Affairs
       l   System Engineers
       l   R&D
       l   Compliance Managers
       l   Regulatory and Compliance Associates

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For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

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