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<br><font size=2 face="sans-serif">M.Linda Helgadóttir, lífeindafræðingur<br>
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<br><font size=1 color=#5f5f5f face="sans-serif">From:
</font><font size=1 face="sans-serif">"Conferences and
Seminars" <training@info.globalcompliancepanel.com></font>
<br><font size=1 color=#5f5f5f face="sans-serif">To:
</font><font size=1 face="sans-serif">lindah@landspitali.is</font>
<br><font size=1 color=#5f5f5f face="sans-serif">Date:
</font><font size=1 face="sans-serif">18.09.2014 09:29</font>
<br><font size=1 color=#5f5f5f face="sans-serif">Subject:
</font><font size=1 face="sans-serif">Applying ISO14971:2012
and IEC62304 - A Guide to Practical Risk Management: 2-day In-person Seminar</font>
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<td bgcolor=white><a href="http://info.globalcompliancepanel.com/cgi-bin18/DM/t/hBwsF0iCdw30BQKE0aywC0Ec" target=_blank></a><font size=6>Seminar</font><font size=3>
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<td bgcolor=white><font size=2 color=#ff8100 face="Arial"><b><i>2-day In-person
Seminar on</i></b></font>
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<td bgcolor=#0a3554><a href="http://info.globalcompliancepanel.com/cgi-bin18/DM/t/hBwsF0iCdw30BQKE0aywD0Ed" target=_blank><font size=4 color=white face="Arial"><b>Applying
ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management</b></font></a><font size=3><br>
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<td width=25% bgcolor=#486573><font size=1 color=white face="Arial">By
<b>Markus Weber </b></font>
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<td><font size=3 color=white face="Arial"><b>REGISTER NOW</b></font></table>
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<td width=50% valign=top><font size=1 color=#2f2f2f face="Arial">Price:
</font><font size=1 color=red face="Arial"><b>$1,595.00</b></font><font size=1 color=#2f2f2f face="Arial">
(for 1 attendee) Register now and save $200. (Early Bird)</font>
<td width=49%><font size=1 color=#5f5f5f face="Arial"><b>Location</b> :
</font><font size=1 color=#ff8100 face="Arial"><b>London, UK </b></font><font size=1 color=#5f5f5f face="Arial"><b>|
October 27th & 28th, 2014 | 9 AM to 6 PM <br>
Venue</b>: </font><font size=1 color=#ff8100 face="Arial"><b>WILL BE ANNOUNCED
SOON </b></font>
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<td colspan=2><font size=1 color=#2f2f2f face="Arial">Course "<b>Applying
ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management</b>"
has been pre-approved by RAPS as eligible for up to 12 credits towards
a participant's RAC recertification upon full completion.</font></table>
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<td width=56%><font size=3><b>Overview:</b></font><font size=1 color=#4f4f4f><br>
Gaps, incorrect or incomplete implementation of safety functionality can
delay or make the certification/approval of medical products impossible.
Most activities cannot be retroactively performed since they are closely
linked into the development lifecycle. Diligent, complete and correct implementation
of risk management from the start of product development is therefore imperative.
This course will introduce all necessary steps to design, implement and
test critical medical devices in a regulatory compliant environment. This
course will additionally address the software risk management and the resulting
interfaces to device level risk management. </font>
<td width=43% rowspan=2 bgcolor=#edf8ff><font size=2 color=#104160 face="Arial"><b>Who
Will Benefit: </b></font>
<ul>
<li><font size=1 color=#4f4f4f face="Arial">Senior quality managers</font>
<li><font size=1 color=#4f4f4f face="Arial">Quality professionals</font>
<li><font size=1 color=#4f4f4f face="Arial">Regulatory professionals</font>
<li><font size=1 color=#4f4f4f face="Arial">Compliance professionals</font>
<li><font size=1 color=#4f4f4f face="Arial">Project managers</font>
<li><font size=1 color=#4f4f4f face="Arial">Design engineers</font>
<li><font size=1 color=#4f4f4f face="Arial">Software engineers</font>
<li><font size=1 color=#4f4f4f face="Arial">Process owners</font>
<li><font size=1 color=#4f4f4f face="Arial">Quality engineers</font>
<li><font size=1 color=#4f4f4f face="Arial">Quality auditors</font>
<li><font size=1 color=#4f4f4f face="Arial">Medical affairs</font>
<li><font size=1 color=#4f4f4f face="Arial">Legal Professionals</font></ul>
<hr><font size=2 color=#104160 face="Arial"><b>About Speaker</b></font><font size=3>
</font><font size=2 face="Arial"><b><br>
Markus Weber </b></font><font size=1 color=#4f4f4f face="Arial"><i><br>
Principal Consultant, System Safety Inc. </i></font><font size=3 color=#4f4f4f face="Arial"><br>
<b><br>
Markus Weber </b>s owner and Principal Consultant with System Safety, Inc.
He specializes in safety engineering and risk management for critical medical
devices. He graduated from Ruhr University in Bochum, Germany with a MS
in Electrical Engineering. Before founding his consulting company, 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.
Over the last 25 years Mr. Weber has helped hundreds of companies, from
startups to Fortune 500 firms, to design safe medical devices. He trained
hundreds of professionals on four continents in practical risk management
and system safety methodologies.</font>
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<td width=100%><font size=2 color=#104160 face="Arial"><b>Agenda:</b></font><font size=1 color=#4f4f4f face="Arial">
</font><font size=1 color=#ff8100 face="Arial"><b><br>
Day 1</b></font>
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<td><font size=1 color=#4f4f4f face="Arial">Lecture 1: <b>Introduction
into Risk Management and Quality System Integration</b> </font>
<ul>
<li><font size=1 color=#4f4f4f face="Arial">Why risk management?</font>
<li><font size=1 color=#4f4f4f face="Arial">Risk Management Lifecycle and
stakeholders</font>
<li><font size=1 color=#4f4f4f face="Arial">Risk Management Benefits</font>
<li><font size=1 color=#4f4f4f face="Arial">How to Implement Risk Management
into ISO13485</font>
<li><font size=1 color=#4f4f4f face="Arial">Tips and tricks</font></ul><font size=1 color=#4f4f4f face="Arial">Lecture
2: <b>Risk Management to ISO 14971:2012 </b></font>
<ul>
<li><font size=1 color=#4f4f4f face="Arial">Risk Management Planning</font>
<li><font size=1 color=#4f4f4f face="Arial">Risk Management Life Cycle</font>
<li><font size=1 color=#4f4f4f face="Arial">Hazard Identification</font>
<li><font size=1 color=#4f4f4f face="Arial">Initial (unmitigated) Risk
Assessment</font>
<li><font size=1 color=#4f4f4f face="Arial">Mitigation Strategies and Priorities</font>
<li><font size=1 color=#4f4f4f face="Arial">Mitigation Architectures</font>
<li><font size=1 color=#4f4f4f face="Arial">Post Mitigation Risk</font>
<li><font size=1 color=#4f4f4f face="Arial">Residual Risk</font>
<li><font size=1 color=#4f4f4f face="Arial">European special requirements
(Z-Annexes)</font>
<li><font size=1 color=#4f4f4f face="Arial">Safety Requirements</font>
<li><font size=1 color=#4f4f4f face="Arial">Hazard Mitigation Traceability</font>
<li><font size=1 color=#4f4f4f face="Arial">Verification Planning</font>
<li><font size=1 color=#4f4f4f face="Arial">Architectures, Redundancy and
Diversity</font>
<li><font size=1 color=#4f4f4f face="Arial">Failure Mode and Effect Analysis</font>
<li><font size=1 color=#4f4f4f face="Arial">Tips and Tricks</font>
<li><font size=1 color=#4f4f4f face="Arial">Q&A </font></ul>
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<td bgcolor=#999999>
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<td><font size=1 color=#ff8100 face="Arial"><b>Day 2 </b></font>
<tr>
<td><font size=1 color=#4f4f4f face="Arial">Lecture 3: <b>Usability and
Risk Management </b></font>
<li><font size=1 color=#4f4f4f face="Arial">Use errors as hazard source</font>
<li><font size=1 color=#4f4f4f face="Arial">User intervention as hazard
mitigation</font>
<li><font size=1 color=#4f4f4f face="Arial">Usability engineering lifecycle</font>
<li><font size=1 color=#4f4f4f face="Arial">Application specification</font>
<li><font size=1 color=#4f4f4f face="Arial">Usability Specification</font>
<li><font size=1 color=#4f4f4f face="Arial">Frequently used functions /
primary operating functions</font>
<li><font size=1 color=#4f4f4f face="Arial">Usability verification / validation</font>
<li><font size=1 color=#4f4f4f face="Arial">Upcoming changes IEC62366:2014</font><font size=1 color=#4f4f4f face="Arial">Lecture
4: <b>Software Risk Management (IEC62304 / FDA software reviewers' guidance):
</b></font>
<ul>
<li><font size=1 color=#4f4f4f face="Arial">Critical Software Issues</font>
<li><font size=1 color=#4f4f4f face="Arial">Software Hazard Mitigation
Strategies</font>
<li><font size=1 color=#4f4f4f face="Arial">Software Item, Unit and System
Definition</font>
<li><font size=1 color=#4f4f4f face="Arial">Software Failures as Hazard
Sources</font>
<li><font size=1 color=#4f4f4f face="Arial">Software Requirements and Design
Specification</font>
<li><font size=1 color=#4f4f4f face="Arial">Software Tools and Development
Environment</font></ul><font size=1 color=#4f4f4f face="Arial">Lecture 5:
<b>Software Risk Management (IEC62304 / FDA software reviewers' guidance):
</b></font>
<ul>
<li><font size=1 color=#4f4f4f face="Arial">Software Unit and Integration
Testing</font>
<li><font size=1 color=#4f4f4f face="Arial">Real-Time System Challenges</font>
<li><font size=1 color=#4f4f4f face="Arial">Software Verification and Validation</font>
<li><font size=1 color=#4f4f4f face="Arial">Mitigation Traceability and
Effectiveness</font>
<li><font size=1 color=#4f4f4f face="Arial">Software Maintenance and Configuration
Control</font>
<li><font size=1 color=#4f4f4f face="Arial">Software Risk Management Process
integration into ISO14971</font>
<li><font size=1 color=#4f4f4f face="Arial">Legacy Software issues</font>
<li><font size=1 color=#4f4f4f face="Arial">FDA documentation requirements</font>
<li><font size=1 color=#4f4f4f face="Arial">Upcoming changes in IEC62304:2014</font>
<li><font size=1 color=#4f4f4f face="Arial">Tips and Tricks</font></ul><font size=1 color=#4f4f4f face="Arial">Lecture
6: <b>Safety / Assurance case </b></font>
<ul>
<li><font size=1 color=#4f4f4f face="Arial">Safety classes</font>
<li><font size=1 color=#4f4f4f face="Arial">Documentation of Basic Safety</font>
<li><font size=1 color=#4f4f4f face="Arial">Documentation of essential
performance</font>
<li><font size=1 color=#4f4f4f face="Arial">External safety</font>
<li><font size=1 color=#4f4f4f face="Arial">Verification of safety properties</font>
<li><font size=1 color=#4f4f4f face="Arial">Assurance case vs. Risk Management
Report</font>
<li><font size=1 color=#4f4f4f face="Arial">Tips and Tricks</font>
<li><font size=1 color=#4f4f4f face="Arial">Q&A</font></ul></table></table>
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