Course "Creating and Implementing an Effective Risk Management System - Why FMEAs by Themselves are Not Risk Management Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

As technologies and innovation push the boundaries for new medical devices, there is an increased emphasis and expectation that such devices shall be free from unacceptable risk to the patient and end-user. In addition several recent standards and guidance documents point to ISO 14971:2007 as the standard for medical device risk management. Many (incorrectly) assume that the use of Failure Mode and Effects Analysis (FMEA) is compliant with the standard and it is the risk management system for their products. A clear understanding of what is effective risk management has thus become a necessity for medical device manufacturers.

This two day interactive seminar will provide a clear understanding of what constitutes a risk management system and the relationship of FMEAs to risk management. It will also provide attendees with the fundamentals and knowledge to create, improve and implement an effective, compliant risk management system in their organizations.

Learning Objective:

  • Understanding the importance of risk management as the apply to relevant Medical Device Regulations (21 CFR Part 820) and Standards (ISO 13485)
  • Recognizing organizational factors that lead to an effective risk management system
  • Integrating the product life-cycle process with risk management
  • Detailed understanding of ISO 14971 Risk Management for Medical Devices
  • Conducting risk analysis and creating risk documents
  • Understanding the relationship and use of tools like Hazard Analysis, FMEA and FTA
  • Advantages and disadvantages of FMEA with respect to risk analysis
  • Developing a compliant Risk Management File
  • Knowing how to use Risk Management Files in post-production activities
  • Knowing how and when to update Risk Management Files

Who will Benefit:

  • Executive Management
  • Product design and development managers and engineers
  • Operation and manufacturing managers and engineers
  • Quality Control
  • Quality Assurance
  • Consultants
  • Project Managers
  • Contract Manufacturers
  • Suppliers to the Medical Device Industry
  • Complaint Handling Teams
  • CAPA Teams

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:00 PM)

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

Session Start Time: 9:00 AM

  • Introduction (15 min)
  • Quality Systems Regulation for medical devices overview and intent (60 min)
    • FDA 21 CFR Part 820 and Risk Management
    • ISO 13485 and Risk Management
    • Risk Management Guidance documents overview
    • Trends and expectations in Risk Management
    • FDA Inspections
  • ISO 14971 Overview (60 min)
    • Risk Management Process overview
    • Concept of Normal and Fault conditions
    • Product Life Cycle Concept
    • Collateral Standards (IEC 63266, HE 75, IEC 60601-1-1 3rd Ed. IEC 62304 Etc.)
    • Key terminology
  • Management Responsibilities (60 min)
    • Roles and responsibilities
    • Risk Acceptability Criteria determination
    • Exercise on Risk Acceptability Criteria
  • Risk Management Plan (30 min)
    • RMP Overview
    • Exercise on RMP
  • Risk Analysis Prerequisites (30 min)
    • Hazard List
    • Harms List
    • Questionnaire
  • Risk Analysis Overview (120 min)
    • Design Input and Design and Development Process
    • Use Case Analysis / Intended Use / User Needs
    • Hazard Analysis
      • Hazard / hazardous situation / harm / severity of harm / risk level
      • Risk Controls
      • Individual Residual Risk Analysis / Risk Benefit Analysis
    • Exercise on Risk Acceptability Criteria and Hazard Analysis

  • Design Output (60 min)
    • Use Failure Mode and Effects Analysis (UFMEA)
    • Design Failure Mode and Effects Analysis (DFMEA)
    • Pros and Cons of FMEA
    • Use of Delectability in DFMEA
    • Fault Tree Analysis
    • Exercise on UFMEA and DFMEA
  • Design Transfer (60 min)
    • Process validation
    • Process Failure Mode and Effects Analysis (PFMEA)
    • Exercise on PFMEA
  • Software Risk Analysis (45 min)
    • Basic Principles
    • Examples
  • Final Risk Analysis Summary Table (60 min)
    • Methods of creating a Risk Analysis Table
    • Overall Residual Risk / Risk Benefit Analysis
    • Exercise on Overall Residual Risk And Risk Benefit Analysis
  • Risk Management Report (30 min)
    • Risk Management Report overview
    • Exercise on Risk management Report
  • Risk Management File (15 min)
  • Risk Management in Post-Production (60 min)
    • Use of Risk Files in Post Production (NCRs, Complaints, CAPAs, Change Control etc.)
    • Updating Risk Management Files
    • Health Hazard Evaluation
    • Case Study / Exercise on Post-production
  • Review and Control of Risk Management Files (15 min)
  • Conclusion (15 min)

Meet Your Instructor

Dr. Vinny Sastri
Ph.D, President, WINOVIA® LLC

Dr. Vinny Sastri, Ph.D is the president of WINOVIA® LLC, a company that provides customized solutions, strategies, and implementation of effective product life cycle management and quality management processes. Dr. Sastri has over 25 years of experience in quality, product development and manufacturing. His areas of expertise include FDA and ISO quality management systems and good manufacturing practices (GMP) for medical devices and pharmaceuticals, product life cycle management and design for Six Sigma, design controls, risk management, CAPA, manufacturing, operational excellence, process validation, supplier controls, change management and plastics and materials.

He is a certified Six Sigma black belt and is also on the faculty of the Association for the Advancement of Medical Instrumentation (AAMI) that provides training on the FDA Quality Systems Regulation and Industry Practice to the medical device industry. He is the author of the book “Plastics in Medical Devices: Properties, Requirements and Applications” published by Elsevier, London in April 2010. He has over 20 publications and 6 patents and has presented at many international conferences and webinars in the United States, Europe and Asia.

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