Upcoming Events at DoubleTree by Hilton Philadelphia Airport
Mon Sep 24, 9:00 AM - Tue Sep 25, 6:00 PM
DoubleTree by Hilton Philadelphia Airport
4509 Island Ave, Philadelphia, PA 19153
Community: Times Square
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.
Event Details
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
S
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
S
