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.
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.
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.
Edwin Waldbusser
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.
Female to Female Hostility @Workplace: All you Need to Know
The Importance of the first 5 seconds when presenting
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
Managing Difficult Employee Conversations
How to Write Effective Audit Observations: The Principles f…
Managing Toxic & Other Employees Who Have Attitude Issues
2025 EEOC & Employers: Investigating Claims of Harassment …
Leadership: Strategic Planning and Decision Making
FDA Proposes Framework to Advance Credibility of AI Models
Reduce Stress in the Workplace: Effective Ways to Handle Co…
ChatGPT and Project Management: Leveraging AI for Project M…
Leverage AI-Powered Tools for Talent Acquisition: Best Prac…
6-Hour Virtual Seminar on Learning the Highlights of Excel …
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Form W-9 Compliance: TIN Verification, B Notices, and Avoid…
How to Give Corrective Feedback: The CARE Model - Eliminati…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Stress, Change And Team Resilience Through Humor: An Intera…
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
AML Regulatory Insight for Q1 2025: Implementing recent cha…
How to Write Right for Better Business Communication
Gossip-Free: Leadership Techniques to Quell Office Chatter
Improving Employee Engagement & Retention Through Stay Inte…
Transforming Anger And Conflict Into Collaborative Problem …