Software Validation for the New FDA Inspections - Webinar

  • ID: 4428086
  • Webinar
  • 60 Minutes
  • NetZealous
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This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.

Why You Should 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. These requirements were developed after analysis by the FDA of many recalled medical devices. In this webinar you will learn the requirements in addition to functional tests that are required to produce a validated software product.

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
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  • Inspectors
  • Auditors
  • Quality and Documentation Personnel within the industry as well as Regulatory
  • Quality
  • Operations and Development
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