Conducting a Software Validation of Medical Device to Meet FDA Requirements


Ed is Keynote Speaker at Compliance key Inc. He is retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing. He now consults internationally in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis. Ed has a B.S. Mechanic........

Overview

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. Software validation is much more than testing.We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.

Why should you attend this webinar?

Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional analyses and tests that FDA feels are necessary to prevent user injuries. These requirements were developed after analysis by the FDA of many recalled medical devices.

Areas Covered in the Session:

Who can Benefit:



Webinar Id: LSHCMEW007

Training Options:

Duration: 90 mins

 12/04/2017

 10.00 AM PT | 01.00 PM ET

 Single Attendee: [Only for one participant]

$179 (Live)                    $319 (Live + Recorded)

 Multiple Attendee: [For a group of 2-5 participants]

$363 (Live)                   $488(Live + Recorded)

 Corporate Attendee: [For a group of 6-10 Participants]

$726 (Live)                   $945(Live + Recorded)

 Recorded: [Six month unlimited access]

$237(Single Attendee) $599 (Unlimited Attendee)

Refund Policy
Upcoming Webinar of Edwin Waldbusser
Past Webinar of Edwin Waldbusser
Upcoming Webinar :Life Sciences and Healthcare
Mobile Medical Apps (Is It a FDA Regulated Device) and Cybersecurity
By: Edwin Waldbusser
When: 10/24/2017 | 10:00 AM PT |01:00 PM ET
Price: $179
Course Description - How to Write and Manage a Change Control System
By: Danielle DeLucy
When: 10/24/2017 | 10:00 AM PT |01:00 PM ET
Price: $179

More Webinar

Past Webinar : Life Sciences and Healthcare
    
Copyright © 2017 Compliance Key . All Rights Reserved. Back to Top