This course provides the attendees with an overview of ISO 14971:2007 and implementation tips for an effective system for managing risk. We provide an overview using flow charts 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.
We look at the elements of Risk Management, including the required documents. This includes:
A Risk Management Plan
Risk Evaluation documentation
Risk verification activities
Risk Management Report
Risk Management File
Obtaining production information
Linking complaints to provide post-production information
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. Because these regulations may also span your organizational structure, this webinar is especially suited for cross functional and cross discipline teams.
Why should you attend:
ISO 14971:2007 is the de facto standard for medical device risk management. It requires more than just Risk Assessment for full compliance. This presentation explains the standard and it application to the device life cycle. 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 the Session:
An overview of ISO 14971 to place the presentation in context
FDA requirements for risk analysis as part of design validation
Recognition status of ISO 14971 by the FDA and for the EU MDD and IVDD
The GHTF guidance document on risk management principles
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)
Who Will Benefit:
Project Managers involved in Design and Development
Quality Engineers assigned to validation activities
Quality staff assigned to Customer Complaints or CAPA management
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.
Event Link - http://bit.ly/1e2naZJ