Boston Professional Events List


ISO 14971 Hazard Analysis at Medical Device - 2017


Date
Aug 17, 2017 - 10:00 AM
Organizer
Compliance4All
Venue
Online Event
Location
161, Mission Falls Ln

Fremont,
CA,
USA,
ZIP: 94539
Phone: 18004479407

Ticket Price: One Dial-in One Attendee Price: $150.00
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: [email protected]

Event Categories
Keywords: Educational, Management , medical , trainin




Comments








Events Calendar

SunMonTueWedThuFriSat
30 31 1 2 3 4 5
6 7 8 9 10 11 12
13 14 15 16 17 18 19
20 21 22 23 24 25 26
27 28 29 30 31 1 2

Tag Cloud

Event Location

Newsletters

Subscribe
VIP Life Time Subscription to our Newsletters!
$399.99
$299.99