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How to Conduct a Human Factors - ISO 62366 and the 2016 FDA Guidance
This Webinar is over| Date | Jul 10, 2019 |
| Time | 12:00 PM EDT |
| Cost | $150.00 |
|
Online
|
Overview:
In this webinar speaker will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test.
Why should you Attend:
We will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test. The post test participant inquiry is critical to validation success. we will describe how to do this.
Areas Covered in the Session:
Required number of Participants
Test Procedure
Qualitative Success Criteria
Choice of Tasks to Validate
Post test Participant Inquiry
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.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: compliance4all14@gmail.com
In this webinar speaker will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test.
Why should you Attend:
We will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test. The post test participant inquiry is critical to validation success. we will describe how to do this.
Areas Covered in the Session:
Required number of Participants
Test Procedure
Qualitative Success Criteria
Choice of Tasks to Validate
Post test Participant Inquiry
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.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: compliance4all14@gmail.com
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