How software requirements are used in validation

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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

Others Details

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