The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post-production risk management program be implemented.
FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard.
One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and FTA consider only fault conditions and are more suited as reliability tools than as product safety tools.
In this seminar we will explain in detail the process of conducting a hazard analysis. The confusing terms “hazard”, hazardous situation”, “harm”, “causative event”, “ALARP”, “risk index”, “benefit/ risk ratio”, and “residual risk” will be explained. We will go step by step through a template for risk analysis so that the process is clear. Examples of hazards and hazardous situations will be discussed. How to deal with residual risk will be discussed.
We will explain how to integrate Human Factors studies into the Hazard Analysis and how to integrate Hazard Analysis into the design program. Risk level can determine the extent of CAPA investigations, validations effort, etc.
Application of ISO 14971 principles to software risk management will be explained.
WHY SHOULD YOU ATTEND?
FDA expects that as part of a product development program risk management will be conducted and risks will be mitigated as far as practical. Risk Analysis is required in a FDA product submission.FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Hazard Analysis is the most powerful of the risk management tools described in ISO 14971 but it is very confusing. Many new concepts are introduced. We will explain these concepts and provide examples so that the process is clear.
Handouts are hazard analysis forms and HA report template.
LEARNING OBJECTIVES
- Explanation of Hazard Analysis terms: hazard, hazardous situation, harm, risk
- Explanation of the hazard analysis process using a template
- Examples of terms will be given
- Hazard analysis examples will be covered step by step
WHO WILL BENEFIT?
- Engineer
- Engineering Manager
- Regulatory Personnel
- QA
FDA expects that as part of a product development program risk management will be conducted and risks will be mitigated as far as practical. Risk Analysis is required in a FDA product submission.FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Hazard Analysis is the most powerful of the risk management tools described in ISO 14971 but it is very confusing. Many new concepts are introduced. We will explain these concepts and provide examples so that the process is clear.
Handouts are hazard analysis forms and HA report template.
- Explanation of Hazard Analysis terms: hazard, hazardous situation, harm, risk
- Explanation of the hazard analysis process using a template
- Examples of terms will be given
- Hazard analysis examples will be covered step by step
- Engineer
- Engineering Manager
- Regulatory Personnel
- QA
Speaker Profile
Edwin Waldbusser, is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
Upcoming Webinars
How to Give Corrective Feedback: The CARE Model - Eliminati…
Why EBITDA Doesn't Spell Cash Flow and What Does
SOPs - How to Write Them to Satisfy those Inspectors
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 …
Tattoos, hijabs, piercings, and pink hair: The challenges …
Trial Master File (TMF)/eTMF, & FDAs Draft Guidance for Ele…
Project Management for Non-Project Managers - How to commun…
Female to Female Hostility @Workplace: All you Need to Know
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…
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Sunshine Act Reporting - Clarification for Clinical Research
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
Understanding the Artificial Intelligence Landscape
Establishing Appropriate Quality Metrics and Key Performanc…
Holiday Stress and Loss: The Art of Stress Resilience in E…
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Using High-Performance Coaching for Managers to Address Per…
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
Is Your Culture Working For or Against Your Success? If You…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
Red flags that can render your OSHA Safety Program Complete…
Onboarding is NOT Orientation - How to Improve the New Empl…
The Anti-Kickback Statute: Enforcement and Recent Updates
How to Prepare For and Host a FDA Inspection and Respond to…
FDA Technology Modernization Action Plan (TMAP) and Impact …
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 …