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Webinar on “Effective Hazard Analysis to Meet FDA and ISO 13485: 2003 Risk Management Requirements”

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(Free Press Release) Hazard and Risk Analysis which provides safety critical design input for the device design, is the starting point for each risk management lifecycle.

Webinar on “Effective Hazard Analysis to Meet FDA and ISO 13485: 2003 Risk Management Requirements”


      

 

Description:

Risk Management lies at the core of the development life cycle of FDA-created Good Manufacturing Processes (GMP’s), namely Quality System Regulations (QSRs), and ISO 13485. Hazard and Risk Analysis which provides safety critical design input for the device design, is the starting point for each risk management lifecycle.

This webinar will give practical guidance and helpful insights on how to efficiently perform a comprehensive hazard analysis and avoid commonly made mistakes. As a result, participants’ organizations will be able to streamline the analysis process and generate a compliant and meaningful document that will lead to valuable design input that meets regulatory requirements.

Yet, performing this Hazard and Risk Analysis is not so simple; because the company has to take into consideration important factors like:

o How detailed does the analysis have to be?

o What is the difference between hazard and harm, hazard and hazard cause, Hazard analysis and FMEA, etc.?

o How do we combine the risk rating when different mitigation measured is 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. It will cover the following areas:

o Structure of a Risk and Hazard Analysis document

o Stakeholders and participants

o How to conduct a hazard analysis meeting

o Meeting ground rules

o Hazard and Harm characteristics

o Methods to identify potential hazards

o Risk and Risk Rating methods

o Risk mitigation strategies

o Risk assessment and Residual Risk

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When:June 18, 10:00 AM PDT | 01:00 PM EDT

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By whom:

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 an 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.

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For whom:

The webinar will benefit

o Project Leaders

o Design Engineers

o Regulatory professionals

o Quality professionals

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Duration: 60 minutes

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To enroll for this webinar, contact

This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Ph: 800-447-9407

Fax: 302-288-6884

PR LINK: http://bit.ly/10WsP1i

 




Webinar on “Effective Hazard Analysis to Meet FDA and ISO 13485: 2003 Risk Management Requirements”

Source: Press Release

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