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
Managing Toxic & Other Employees Who Have Attitude Issues
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
Analytical Method Validation Under Good Laboratory Practic…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Sunshine Act Reporting - Clarification for Clinical Research
Onboarding New Hires: Leverage the Potential of Artificial …
Do's and Don'ts of Giving Effective Feedback for Performanc…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Using Behavior Based Interviewing for Finding the Best Matc…
How to Document Employee Discussions and Why it is Important
Project Management for HR, Administrative Professionals, an…
Stressed Out: How to Handle Conflict, Difficult People and …
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Marketing to Medicare or Medicaid Beneficiaries - What You …
Understanding the Artificial Intelligence Landscape
Best Practices for Working With Vendors and Suppliers
Accounting For Non Accountants : Debit, Credits And Financi…
Principles & Practices for the Cybersecurity of Legacy Medi…
Independent Contractor vs. Employee New Rule Issued by The …
The Top Ten Excel Functions Everyone Should Know
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Clinical Trial Systems: The Trial Master File (TMF) and Ele…
Dealing With Difficult People In Life & Work
Improving Employee Engagement & Retention Through Stay Inte…
Fair Lending in Q2 2024: new regulations, examinations, and…
FDA Regulation of Artificial Intelligence/ Machine Learning
Form 1099 Update 2024: Latest Forms, Rules and Reporting Re…
Coming Soon - New Minimum Salary Levels for Exempt Employee…
Beyond ‘Illegal’ Interview Questions: What Recruiters & Hir…
Bootcamp for New Managers and Supervisors: Avoid These 7 Mi…
Writing Techniques for Auditors and Risk Management Profess…
Coaching & Retaining Your Talent – Putting the WOW into Qua…
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Emotional Intelligence: Mastering the Emotions of Great Lea…
Building Fair Chance Hiring Policies in 2024
Effectively Handle Toxic People for Better Productivity and…
Third-Party Relationships: Risk Management: What All Bankin…
HR 101 - Bootcamp Basics for New Human Resource Professiona…
How to Manage and Resolve Conflict in the Workplace
Impact Assessments For Supplier Change Notices
Performance Management with Bottom-Line Results
How to Give Corrective Feedback: The CARE Model - Eliminati…
Human Error Reduction Techniques for Floor Supervisors
Credit Risk Discipline Tools - Implementing 14 Tools for Cr…
FDA Compliance And Laboratory Computer System Validation