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Software Validation for the New FDA Inspections

By: Edwin Waldbusser
Recorded Session
Duration
60 Minutes
Training Level
Intermediate to Advanced

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Recorded Session

Training CD

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Webinar Details

The imperative aspect of Software Validation is the backbone of the software industry that deals with software authenticity, efficiency, and removes any invalidated bug that might risk the endurance of your software. 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 invalidation. 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 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 the 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.

AREA COVERED

  • Software Validation more than testing
  • Requirements traceability
  • Risk analysis
  • Unit, Integration, and System testing
  • Algorithm validation
  • Challenges to the software
  • Configuration management

LEARNING OBJECTIVES

In this webinar you will learn the requirements in addition to functional tests that are required to produce a validated software product, also this webinar will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product.

WHO WILL BENEFIT?

  • Engineer
  • Engineer Management
  • Software Engineer
  • Programmer
  • Quality Assurance
  • Regulatory

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 the 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.

  • Software Validation more than testing
  • Requirements traceability
  • Risk analysis
  • Unit, Integration, and System testing
  • Algorithm validation
  • Challenges to the software
  • Configuration management

In this webinar you will learn the requirements in addition to functional tests that are required to produce a validated software product, also this webinar will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product.

  • 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 areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.