Medical Devices by their very nature must be safe for human use and must meet the requirements for which they have been designed. The process that identifies the risks associated with a medical device that could make the device unsafe or not function as intended is called Risk/Hazard Analysis.
21 CFR Section 820 requires that comprehensive risk analysis be performed as part of the medical device regulatory submissions process and throughout the product’s lifecycle. ISO 14971 is the risk management standard for medical devices. Its purpose is to help manufacturers establish a risk management process that can be used to identify hazards, estimate and evaluate risks, and develop, implement, and monitor the effectiveness of risk control measures. This webinar will discuss both the regulatory requirements and the process for conducting effective Risk/Hazard Analysis.
WHY SHOULD YOU ATTEND?
The secret to preventing medical device recalls or at least minimizing their impact is sound Risk/Hazard Analysis. Aside from being required, it is absolutely essential and necessary to the development and fielding of medical devices that offer a significant level of protection for patients and manufacturers alike.
The seminar will explore the basic principles of risk management and planning as they relate to medical device design and as required by the FDA. It will present a logical process for risk management from risk identification through evaluation/rating and mitigation.
The tools and techniques of Risk Analysis and the rating process used to evaluate the risks identified will be presented and discussed – Fault Tree Analysis, Failure Mode Effects Analysis, and Failure Mode Effects and Criticality Analysis.
LEARNING OBJECTIVES
- Why Risk/Hazard Analysis is important
- Risk Assessment Defined
- Regulatory Requirements
- Risk Management Process – The Risk Management Plan
- Risk Management Documentation
- Risk Analysis Processes and Techniques
- Asking the Right Questions
- The Evaluation/Analysis Tools – FTA, FMEA, and FMECA
- Risk Control/Mitigation
WHO WILL BENEFIT?
- Medical Device Engineers
- Scientists
- Design Engineers,
- Regulatory Associates Etc.
- Managers,
- Associate Directors,
- Directors and Associates of all levels
The secret to preventing medical device recalls or at least minimizing their impact is sound Risk/Hazard Analysis. Aside from being required, it is absolutely essential and necessary to the development and fielding of medical devices that offer a significant level of protection for patients and manufacturers alike.
The seminar will explore the basic principles of risk management and planning as they relate to medical device design and as required by the FDA. It will present a logical process for risk management from risk identification through evaluation/rating and mitigation.
The tools and techniques of Risk Analysis and the rating process used to evaluate the risks identified will be presented and discussed – Fault Tree Analysis, Failure Mode Effects Analysis, and Failure Mode Effects and Criticality Analysis.
- Why Risk/Hazard Analysis is important
- Risk Assessment Defined
- Regulatory Requirements
- Risk Management Process – The Risk Management Plan
- Risk Management Documentation
- Risk Analysis Processes and Techniques
- Asking the Right Questions
- The Evaluation/Analysis Tools – FTA, FMEA, and FMECA
- Risk Control/Mitigation
- Medical Device Engineers
- Scientists
- Design Engineers,
- Regulatory Associates Etc.
- Managers,
- Associate Directors,
- Directors and Associates of all levels
Speaker Profile
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer, and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars on a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.
Upcoming Webinars
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Documenting Misconduct that Will Stand Up in Court
Marketing to Medicare or Medicaid Beneficiaries - What You …
Trial Master File (TMF)/eTMF, & FDAs Draft Guidance for Ele…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Project Management for Non-Project Managers - How to commun…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Humane Layoffs: How to Let People Go with Compassion and De…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Sunshine Act Reporting - Clarification for Clinical Research
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Female to Female Hostility @Workplace: All you Need to Know
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
Understanding the Artificial Intelligence Landscape
Holiday Stress and Loss: The Art of Stress Resilience in E…
Establishing Appropriate Quality Metrics and Key Performanc…
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
Using High-Performance Coaching for Managers to Address Per…
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Is Your Culture Working For or Against Your Success? If You…
Red flags that can render your OSHA Safety Program Complete…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
The Anti-Kickback Statute: Enforcement and Recent Updates
Onboarding is NOT Orientation - How to Improve the New Empl…
Eliminate Harmful And Unproductive Drama In The Workplace
3-Hour Virtual Seminar on Chat GPT for Project Management i…
FDA Technology Modernization Action Plan (TMAP) and Impact …
How to Prepare For and Host a FDA Inspection and Respond to…
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Managing Toxic & Other Employees Who Have Attitude Issues
Building GMP Excellence: A Guide to Implementing Compliant …
Improving Employee Engagement & Retention Through Stay Inte…
Human Error Reduction Techniques for Floor Supervisors
Excel Power Skills: Master Functions, Formulas, and Macros …