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2-day In-person Seminar On Applying ISO14971 And IEC62304 - A Guide To Practical Risk Management At Philadelphia

2-day In-person Seminar On Applying ISO14971 And IEC62304 - A Guide To Practical Risk Management At Philadelphia

Views: 1581

11/07/2013 - 11/08/2013

DoubleTree by Hilton Hotel Philadelphia Center City
237 South Broad Street
Philadelphia, PA 19107-5686

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Add to Your Calendar 11-07-2013 00:00:00 11-08-2013 00:00:00 11 2-day In-person Seminar On Applying ISO14971 And IEC62304 - A Guide To Practical Risk Management At Philadelphia Overview: This seminar covers the compliance issues relating to ISO 14971, IEC 62304 and IEC60601-1:2005. Especially the cross-standard and practical means to integrate activities to cover all three requirements documents is presented.  Day 1 – Agenda Lecture 1: (ISO 14971): Risk Management Planning Risk Management Life Cycle Hazard Identification Hazard Domains Hazard Latency Issues Risk Rating Methods Initial (unmitigated) Risk Assessment Mitigation Strategies and Priorities Mitigation Architectures Lecture 2: (ISO 14971): Alarm Systems as Mitigations Risk Control Bundles Post Mitigation Risk Residual Risk Safety Integrity Levels Usability as Hazard Source and Mitigation Safety Requirements Hazard Mitigation Traceability Verification Planning Architectures, Redundancy and Diversity Failure Mode and Effect Analysis / FTA Verification Strategies System Validation / Mitigation Validation Day 2 – Agenda Lecture 3: (IEC60601-1:2005): References to Risk Management Section 4 Risk Related Issues Compliance for Non-Software Related Issues The IEC TRF (technical report form) Special PEMS Issues PEMS and IEC62304 Lecture 4: (IEC62304): Critical Software Issues Software Hazard Mitigation Strategies Software Item, Unit and System Definition Software Failures as Hazard Sources Software Requirements and Design Specification Software Tools and Development Environment Software Unit and Integration Testing Real-Time System Challenges Software Verification and Validation Mitigation Traceability and Effectiveness Who Will Benefit: Project Managers Regulatory / Compliance Managers and Specialists Quality Assurance Managers System Engineering Hardware Engineers Software Engineers About Speaker: Markus Weber, Principal Consultant with System Safety, Inc... DoubleTree by Hilton Hotel Philadelphia Center City GlobalCompliancePanel true MM/DD/YYYY

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Overview:

This seminar covers the compliance issues relating to ISO 14971, IEC 62304 and IEC60601-1:2005. Especially the cross-standard and practical means to integrate activities to cover all three requirements documents is presented. 

Day 1 – Agenda

Lecture 1: (ISO 14971):

  • Risk Management Planning
  • Risk Management Life Cycle
  • Hazard Identification
  • Hazard Domains
  • Hazard Latency Issues
  • Risk Rating Methods
  • Initial (unmitigated) Risk Assessment
  • Mitigation Strategies and Priorities
  • Mitigation Architectures

Lecture 2: (ISO 14971):

  • Alarm Systems as Mitigations
  • Risk Control Bundles
  • Post Mitigation Risk
  • Residual Risk
  • Safety Integrity Levels
  • Usability as Hazard Source and Mitigation
  • Safety Requirements
  • Hazard Mitigation Traceability
  • Verification Planning
  • Architectures, Redundancy and Diversity
  • Failure Mode and Effect Analysis / FTA
  • Verification Strategies
  • System Validation / Mitigation Validation

Day 2 – Agenda

Lecture 3: (IEC60601-1:2005):

  • References to Risk Management
  • Section 4 Risk Related Issues
  • Compliance for Non-Software Related Issues
  • The IEC TRF (technical report form)
  • Special PEMS Issues
  • PEMS and IEC62304

Lecture 4: (IEC62304):

  • Critical Software Issues
  • Software Hazard Mitigation Strategies
  • Software Item, Unit and System Definition
  • Software Failures as Hazard Sources
  • Software Requirements and Design Specification
  • Software Tools and Development Environment
  • Software Unit and Integration Testing
  • Real-Time System Challenges
  • Software Verification and Validation
  • Mitigation Traceability and Effectiveness

Who Will Benefit:

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

About Speaker:

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 a 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.

DATE, VENUE & PRICE:

Location: Philadelphia | November 7th & 8th, 2013 | 9 AM to 6 PM EDT

Venue: DoubleTree by Hilton Hotel Philadelphia Center City

Price: $1,295.00

Register now and save $200. (Early Bird)

Until September 15, Early Bird Price: $1,295.00

From September 16 to November 05, Regular Price: $1,495.00

Contact Information:

Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884

Email: support@globalcompliancepanel.com

Website: https://www.globalcompliancepanel.com

LIVE CHAT SUPPORT ALSO - http://www.globalcompliancepanel.com/chat/client.php

EVENT Linkhttp://bit.ly/1hp3Fxg

Net Zealous LLC,

DBA GlobalCompliancePanel,

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA 

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Website: http://bit.ly/1hp3Fxg...
Conference/Event Dates: 11/07/2013 - 11/08/2013
Classification: B2B
Primary Industry: Pharmaceutical
Other Industries: Business, Pharmaceutical, Professional Healthcare, Safety
Audience: Project Managers
Regulatory / Compliance Managers and Specialists
Quality Assurance Managers
System Engineering
Hardware Engineers
Software Engineers
Venue: DoubleTree by Hilton Hotel Philadelphia Center City
Venue Phone: (215) 893-1600
Venue Type: Indoor - Hotel

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2-day In-person Seminar On Applying ISO14971 And IEC62304 - A Guide To Practical Risk Management At Philadelphia

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