Overview: 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.
The course will emphasise the implementation of risk management into the development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking.
This seminar will address the system level issues of risk management as well as the increasingly important software related issues of critical systems. It will help to comply with regulatory requirements with minimized overhead and resource burden.
Why should you attend: Gaps, incorrect or incomplete implementation can delay or make the certification/approval of 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.
Seminar Content: India Seminar 2012 at Mumbai
Day 1 - 8th August 2012
Lecture 1
• Risk management planning
• Risk management life cycle
• Hazard identification
• Hazard domains
• Hazard latency issues
• Risk rating methods
• Initial (unmitigated) risk assessment
• Q & A Session
Lecture 2
• Mitigation strategies and priorities
• Mitigation architectures
• Alarm systems as mitigations
• Risk control bundles
• Post mitigation risk
• Residual risk
• Safety Integrity levels
• Q & A Session
Day 2 - 9th August 2012
Lecture 3
• 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
• Q & A Session
Lecture 4
• 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
• Q & A Session
Who Will Benefit
• Pharmacoepidemiology
• Regulatory Affairs
• Clinical Safety Staff
• Pharmacovigilance Specialists
• Regulatory Affairs Professionals
• Quality Management Specialists
• Drug Safety and Pharmacovigilance
• Regulatory Affairs
• Clinical Development
• Executives (including C-Level) with any legal responsibility for drug safety
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 and Venue:
8th and 9th August, 2012 at Mumbai
Conference Timings: 9:00 am - 6:00 pm
Venue: Intercontinental The LaLit
Sahar Airport Road, Andheri East
Mumbai - 400059 INDIA
Price – Rs 22000
Contact Information:
Event Coordinator
Phone number: +91 80-3247-3694 / +91 80-3201-4957
FAX : +91 80-2642-1483
Email: customersupport@globalcompliancepanel.com
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