Event Location

Neighborhood: Upper West Side

Online

161 Mission Falls Lane, Suite 216


Fremont, CA 94539

Description

In this seminar we will explain in detail the process of conducting a hazard analysis.


Start on : August 17, 2017 10:00 AM Thursday
End on : August 17, 2017 11:00 AM Thursday

Event Details

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.
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.

Areas Covered in the Session:
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

Who Will Benefit:
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 US and internationally 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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

People Attending ISO 14971 Hazard Analysis at Medical Device - 2017

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