How software requirements are used in validation
Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval.
Mon, Jan 29, 2018 10:00 AM (PST)
Online,
Fremont,
California
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Overview:
This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.
Why should you Attend:
Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional requirements,analyses and tests that FDA feels are necessary to prevent user injuries.
Areas Covered in the Session:
Software Validation more than Testing
Requirements Traceability
Risk Analysis
Unit,Integration and System Testing
Algorithm Validation
Challenges to the Software
Configuration Management
Who Will Benefit:
Engineer
Engineer Management
Software Engineer
Programmer
Quality Assurance
Regulatory
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.
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
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