Course "Software Risk Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Description:
The seminar will address the specific challenges software poses for the risk management process. Basic risk management concepts will be introduced and then applied to software specific applications.
Why you should attend:
Risk Management is a regulatory and statutory requirement for medical devices. The generic procedure to perform risk management is outlined in ISO14791, however, as soon as software is used challenges arise. How to address these specific software issues and the application of FDA and IEC requirements for development of safety-critical software used in medical devices is the content of this seminar.
Who Will Benefit:
- Project managers
- Software Engineerrs
- Regulatory specialists
- Quality assurance specialists
- Documentation specialists
- Test managers
- Software team leaders and lead developers
Agenda:
Day 1 Schedule
Lecture 1 (90 Mins):
Legal and regulatory requirements for risk management
Risk management and quality systems
Lecture 2 (90 Mins):
Risk Management Basics
- What are hazards / hazardous situations
- Hazard characteristics
- Risk and risk rating
- Residual risk
Lecture 3 (90 Mins):
Software failures
- Random and systematic faults
- Fault control means
- Software failure effects
Lecture 4 (90 Mins):
System Architectures
Software Architecture
Software Tools and Methods
Multiprocessor systems
Real-time challenges
Day 2 Schedule
Lecture 1 (90 Mins):
Software Criticality Classification
- IEC criticality classed
- FDA level of concern
Lecture 2 (90 Mins):
The 62304 Development Process
- Life Cycle
- Documentation
Comparison to FDA requirements
Lecture 3 (90 Mins):
Software Risk Management
Software Configuration Management
Software Problem Resolution
Software Maintenance
Lecture 4 (90 Mins):
Legacy Software
Risk-based verification
Third-party software (SOUP, COTS)
Speaker:
Markus Weber
Principal Consultant, System Safety Inc.
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.
Location: Philadelphia, PA Date: September 24th & 25th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: DoubleTree by Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, PA 19153
Price:
Price: $1,495.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $4,485.00 $7,475.00 You Save: $2,990.00 (40%)*
Register for 10 attendees Price: $8,222.00 $14,950.00 You Save: $6,728.00 (45%)*
Sponsorship Program benefits for seminar
For More Information- https://www.globalcompliancepanel.com/control/sponsorship
Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com
Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901822SEMINAR?seo
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