Course offering number:1007-711
Course ID:
2147
Risk Hazard Assessment for Validation– ISO14971, HACCP, FMEA, FAULT TREE
In Conjunction with Medical Device Summit
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This session will benefit professionals working within the medical device and pharmaceutical industries who want to learn how to evaluate risk
as part of a validation project. It will be especially valuable to:
• Validation professionals
• Managers
• QA staff
• Software developers
• Medical device design personnel
• Auditors
Description
This 90-minute accredited online training course is designed to introduce the concept of Risk/Hazard Assessment. It addresses when to do an
assessment, what tools are available, what the FDA expects and how it can save you time, money and resources. By understanding Risk
Assessment participants will be able to use the techniques and tools to: prioritize and plan validation projects and submissions, plan testing, and
define “what is enough “and when they are “done.”
Module 1: Define computer system
validation:
• FDA's definition
• Tasks
Module 2: FDA Guidelines:
• Least burdensome approach
• The role of Risk Assessment
• When is Risk Assessment required
Module 3: Tools and Techniques:
• ISO14971
• FMEA
• Fault Tree
• HACCP
• Root Cause-5 Why's
Question and Answer Session
About Medical Device Summit
Medical Device Summit publishes news, technology, trends, regulations, and opinions, as well as offers educational, career advancement and networking opportunities to the global medical device and diagnostics industry. This information exchange is facilitated through ePublishing, digital and live events. By providing such an exchange of knowledge and technologies, MedicalDeviceSummit hopes to help advance the progress of the global medical device and diagnostic industry, thus, contributing to a healthier world.
MedicalDeviceSummit.com is an online meeting place and industry specific web site for the global medical device industry. The content is a mix of journalistic-style articles, technical articles, blogs, white papers, press releases and news.
For more information visit their website at www.medicaldevicesummit.com or email rbiros@InnovativePublishing.net.