Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency training seminars presented by ComplianceOnline register now on FindaSeminar.com

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Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency  

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For:

Project managers, Quality managers and staff, R & D managers and staff, Regulatory and compliance managers and staff, Anyone with risk management responsibilities

Cost:   

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Seminar Summary:

The medical device risk management (ISO 14971) course will be given using an interactive workshop format taking attendees through all of the risk management activities required by ISO 14971. (see full course description)

 

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Training Course Syllabus:


Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency

Course Description:

The course is designed for Medical Products Manufacturers. The course will be taught for Medical Devices and Combination Products, but will also be of benefit to Pharmaceutical Manufacturers.



Learning Objectives:

Upon completion of the course, the participants will have learned how to implement good risk management principles into medical products manufacturing operations such as medical devices, combination products, and pharmaceuticals:

  • Understand what are the current issues and recommended solutions
  • How to implement the ISO 14971 framework
  • Use a Traceability Report for improved risk management operations
  • How to Use Standards to Facilitate Product-to-Market Achievements
  • How to Use Risk Management to Identify the Critical Success Factors
  • Key implementation issues related to Risk Management
  • Using Risk Management to identify key opportunities for the organization
  • Risk Integration Issues, especially related to the Quality System and Design Controls
  • Use of appropriate risk management tools beyond FMEA
Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency Course Outline:

Day One (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

Introduction
What is risk management?
Global requirements
ISO 14971
New European requirements and EN/ISO 14971:2012
Risk management essentials and requirements
Risk management philosophy
Role of Management
Establishing a risk management policy
Required inputs
Developing a workable policy (Exercise)
Risk management planning
Necessary elements
Relationship with quality planning
Risk acceptability criteria/constructing a risk chart
Defining the product
Measuring risk (Exercise)
How to establish risk acceptability criteria
EN/ISO 14971:2012 requirements
Construct a practical example
Preliminary analysis
Safety analysis (Exercise)
Hazards and hazardous situations
Identifying hazards and hazardous situations (Exercise)
Risk Analysis tools
What's available
Use and utility of tools (Exercise)
Estimating risk
Quantitative and qualitative risk estimation (Exercise)
Pitfalls such as software
Practical example (Exercise)
Using standards and risk management
New guidance from ISO
Risk Evaluation and Risk Control
Using a risk chart (Exercise)
Use of ALARP
Option analysis for risk control


Day Two (8:30 AM – 4:30 PM)

Risk Control (continued)
The iterative process
Practical example (Exercise)
Verification, residual risk and completeness
Satisfying EN/ISO 14971:2012
Risk/benefit analysis
EN/ISO 14971:2012 requirement
How to do it?
Overall residual risk & the risk management report
New ISO guidance on evaluating overall residual risk
Content and use of the Risk Management Report
Assessing production & post-production information
What are the requirements?
What you need to do
New guidance from ISO
Wrap up
Risk management philosophy
Risk management and the quality management system
Helpful hints

Seminar Summary:

The medical device risk management (ISO 14971) course will be given using an interactive workshop format taking attendees through all of the risk management activities required by ISO 14971. (see full course description)

print this agenda print agenda for the Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency training seminar

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