Hazard Analysis vs. FMECA – Differences and Commonalities - Webinar By GlobalCompliancePanel
Description
Overview: The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design.
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- posted:
- 7/5/2012
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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.,
design.
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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Who Will Benefit:
l Project Managers
l Regulatory Affairs
l System Engineers
l R&D
l Compliance Managers
l Regulatory and Compliance Associates
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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