Hazard Analysis following ISO 14971

MessageThis Webinar is over
Date Jun 7, 2017
Time 01:00 pm ET
Cost $199.00
Online
Overview
The US FDA expects that as part of a product development Design Control Program risk management will be conducted.
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 ISO 14971 risk management training we will explain in detail the process of conducting a hazard analysis. The confusing terms “hazard”, hazardous situation”, “harm”, “causative event”, “ALARP”, “risk index”, “residual risk” will be explained. We will go step by step through a template for hazard analysis so that the process is clear. Examples of hazards and hazardous situations will be discussed. Also, how to deal with residual risk will be discussed. We will go step by step through a typical hazard analysis.
We will explain how to integrate Human Factors studies into the Hazard Analysis and how to integrate Hazard Analysis into the design program.
Why Should You Attend
FDA expects that as part of a product development program risk management will be conducted. 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.
Areas Covered in this Webinar
explanation of Hazard Analysis terms hazard analysis process explanation using a template examples of terms will be given hazard analysis examples will be covered step by step
Learning Objectives
Learn to conduct a meaningful hazard analysis
Who Will Benefit
Engineering personnel
Software developers
QA
Management
 
For more detail please click on this below link:
http://bit.ly/2moVzlU
 
Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Fax: +1-516-900-5510

 


comments powered by Disqus
Create your own event
Turn your passion into a business.
Join our mailing list