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Risk Management in Medical Devices Industry US Seminar 2012 at Boston

VIEWS: 30 PAGES: 2

The course will introduce the main elements of risk management and the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management as a mandatory component of almost any activity in the medical device industry.

More Info
									                                                                                                                                     


    2-day In-person Seminar on
 
     Risk Management in Medical Devices Industry

    RAPS Approved. Earn 12 RAC Points                                                                                                 


    Date & Time:                                                                                 Register Now                         

     April 12th and April 13th
                                        8 AM PDT to 5 PM PDT
     2012

     Duration: 2 Days                   Instructor: Markus Weber                            Instructor Profile:

     Location: Boston Marriott
                                        Price : $1695.00   (for one participant)                          Markus Weber
     Long Wharf
                                                                                                   Principal Consultant, System
                                                                                                             Safety Inc.

    Overview:
                                                                                            Markus Weber, Principal
    The course will introduce the main elements of risk management and                      Consultant with System Safety, Inc.,
    the application of risk management principles and requirements to                       specializes in safety engineering and
    the medical device development cycle. Risk management has become                        risk management for critical medical
    the method of choice to ensure an effective and safety oriented                         devices. He graduated from Ruhr
    device development. International consensus, reflected in globally                      University in Bochum, Germany with
                                                                                            a MS in Electrical Engineering.
    applicable standard requirements, has led to risk management as a
                                                                                            Before founding System Safety, Inc.,
    mandatory component of almost any activity in the medical device
                                                                                            he was a software safety engineer
    industry.                                                                               for the German approval agency,
                                                                                            TUV. Since 1991, Mr. Weber has
    The course will emphasise the implementation of risk management                         been a leading consultant to the
    into the development and maintenance process. It will use real-life                     medical device industry on safety
    examples and proven tips and tricks to make the application of risk                     and regulatory compliance issues,
    management a practical and beneficial undertaking.                                      specifically for active and software-
                                                                                            controlled devices. In conjunction
                                                                                            with the FDA, he has published
    This seminar will address the system level issues of risk management
                                                                                            works on risk management issues
    a s well as the increasingly important software related issues of                       and software-related risk
    critical systems. It will help to comply with regulatory requirements                   mitigations. Mr. Weber has helped
    with minimized overhead and resource burden.                                            multiple companies, from startups to
                                                                                            Fortune 500 firms. ...more

    Areas Covered in the Session:

                                                                                           Suggest a Topic       More Webinars
    Day 1, April 12, 2012
                                                                                             Your Necessity is our Priority
    Lecture 1:


       l   Risk management planning
       l   Risk management life cycle
       l   Hazard identification
                                                                                                              
       l   Hazard domains
       l   Hazard latency issues
       l   Risk rating methods
       l   Initial (unmitigated) risk assessment
       l   Q&A Session


    Lecture 2:

                                                                                    
       l   Mitigation strategies and priorities
       l   Mitigation architectures
       l   Alarm systems as mitigations
       l   Risk control bundles
       l   Post mitigation risk
       l   Residual risk
       l   Safety Integrity levels
       l   Q&A Session


    Day 2, April 13, 2012


    Lecture 3:


       l   Usability as hazard source and mitigation
       l   Safety requirements
       l   Hazard mitigation traceability
       l   Verification planning
       l   Architectures, redundancy and diversity
       l   Failure mode and effect analysis / FTA
       l   Verification strategies
     l   System validation / mitigation validation
     l   Q&A Session


 Lecture 4:


     l   Critical software issues
     l   Software hazard mitigation strategies
     l   Software item, unit and system definition
     l   Software failures as hazard sources
     l   Software requirements and design specification
     l   Software tools and development environment
     l   Software unit and integration testing
     l   Real-time system challenges
     l   Software verification and validation
     l   Mitigation traceability and effectiveness
     l   Q&A Session


 Click here to register for this webinar


  Who Will Benefit:


     l   Project Managers
     l   Regulatory / Compliance Managers and Specialists
     l   Quality Assurance Managers
     l   System Engineering
     l   Hardware Engineers
     l   Software Engineers



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



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