Mitigating and Managing Risk for Medical Devices in Compliance with ISO 14971
WebcastFaculty
OVERVIEW
Mitigating and Managing Risk for Medical Devices in Compliance with ISO 14971 is organized by OnlineCompliancePanel and would be held on Jun 8, 2017.
The target audience for this medical event for Validation professionals, Design Engineers, Project Managers involved in Design and Development, Quality Engineers assigned to validation activities Quality Auditors, Managers, Quality staff assigned to Customer Complaints or CAPA management, Systems engineers responsible for developing requirements, Software developers, Test Engineers, Regulatory Affairs.
Conference Objectives are :
ISO 14971 is the de facto standard for medical device risk management. It requires more than just Risk Assessment or an FMEA. Your Risk Management program should be able to answer these questions easily. If not, then your team needs to attend.
• Do you have a documented method to combine frequency and severity to calculate risk?
• Do have a formally approved Risk Management Plan that applies to your medical device?
• Do you apply risk reduction methods in the correct order?
Have you documented the risk verification in the Risk Management Report?
• Does your manufacturing process control, especially validated processes, regularly update you Risk Management File?
• Have you integrated you complaint system with the Risk Management File to evaluate your frequency and severity estimates?
Areas Covered in this Webinar :
• An overview of ISO 14971 to place the presentation in context.
• Key risk management terms & definitions.
• FDA requirements for risk analysis as part of design validation.
• Incorporating risk management throughout the design control process.
• The risk management process in ISO 14971:2007 and the EU variant in EN ISO 14971:2012.
• The GHTF guidance document on risk management principles.
• Describe relevance of ISO 14971 and the ISO 13485 revision.
• Developing a Risk Evaluation Matrix for your product.
• Failure Modes and Effects Analysis (FMEA).
• Fault Tree Analysis (FTA).
• Hazard Analysis and Critical Control Point (HACCP).
This course provides the attendees with an overview of ISO 14971 and implementation tips for an effective system for managing risk. We provide an overview that shows each of the elements of a Risk Management system and how they fit together. This approach helps the participant understand the essential structure and the required elements.
You will learn when written procedures are required, when (and how) to name designated individuals, when (and how) to formally designate units, and the records you must keep.
Additional details will be posted as soon as they are available.
The target audience for this medical event for Validation professionals, Design Engineers, Project Managers involved in Design and Development, Quality Engineers assigned to validation activities Quality Auditors, Managers, Quality staff assigned to Customer Complaints or CAPA management, Systems engineers responsible for developing requirements, Software developers, Test Engineers, Regulatory Affairs.
Conference Objectives are :
ISO 14971 is the de facto standard for medical device risk management. It requires more than just Risk Assessment or an FMEA. Your Risk Management program should be able to answer these questions easily. If not, then your team needs to attend.
• Do you have a documented method to combine frequency and severity to calculate risk?
• Do have a formally approved Risk Management Plan that applies to your medical device?
• Do you apply risk reduction methods in the correct order?
Have you documented the risk verification in the Risk Management Report?
• Does your manufacturing process control, especially validated processes, regularly update you Risk Management File?
• Have you integrated you complaint system with the Risk Management File to evaluate your frequency and severity estimates?
Areas Covered in this Webinar :
• An overview of ISO 14971 to place the presentation in context.
• Key risk management terms & definitions.
• FDA requirements for risk analysis as part of design validation.
• Incorporating risk management throughout the design control process.
• The risk management process in ISO 14971:2007 and the EU variant in EN ISO 14971:2012.
• The GHTF guidance document on risk management principles.
• Describe relevance of ISO 14971 and the ISO 13485 revision.
• Developing a Risk Evaluation Matrix for your product.
• Failure Modes and Effects Analysis (FMEA).
• Fault Tree Analysis (FTA).
• Hazard Analysis and Critical Control Point (HACCP).
This course provides the attendees with an overview of ISO 14971 and implementation tips for an effective system for managing risk. We provide an overview that shows each of the elements of a Risk Management system and how they fit together. This approach helps the participant understand the essential structure and the required elements.
You will learn when written procedures are required, when (and how) to name designated individuals, when (and how) to formally designate units, and the records you must keep.
Additional details will be posted as soon as they are available.
SPECIALITIES
Healthcare TechnologyNuclear Pharmacy
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