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Software Validation Program That will Satisfy FDA Requirements - 2017

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60 Minutes
Conference (Online)
Programmer, Quality assurance, Regulatory
Online / Distance Learning Course

This course will teach how to conduct a software validation program that will

satisfy FDA requirements and produce a safe product.

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 management
    Software engineer
    Quality assurance

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]

Full Details & Registration Link:

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