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Faculty: Edwin Waldbusser


  • Date: 2/2/2021 01:00 PM - 2/2/2021 02:00 PM
  • Location: Online Event

Description

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.

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/ design control

Who Should Attend:

  • Software Developers
  • Software Engineers
  • IT Personnel
  • Device Development Managers
  • Systems engineers responsible for developing requirements
  • Test Engineers
  • Quality System auditors
  • Engineering managers and personnel