VIEWS: 30 PAGES: 2 CATEGORY: Medicine POSTED ON: 2/28/2012
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.
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 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. 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