Call us at +1-(510)-868-1040

Login Register

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.


  • Software Validation more than Testing
  • Requirements Traceability
  • Risk Analysis
  • Unit,Integration and System Testing
  • Algorithm Validation
  • Challenges to the Software
  • Configuration Management
     

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

Edwin Waldbusser is a consultant retired from industry after 20 years of experience in the management of the development of medical devices (5 patients). He has been consulting in the areas of design control, risk analysis, and software validation for the past 8 years. He has a B.S. 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.

View all trainings by this speaker
 
On Demand

Transcript

PDF Transcript of the Training which are available once the webinar is completed.(Transcript for single user only)

$179

Downloadable recorded session

Get unlimited access to the link for six months.

$239

Training CD

Free shipment within 72 Hours, from the date of webinar completion.

$350

  

MAR 11, 2020 AT 1PM EST

Form W-4 for 2020: Whats New? Whats Changed?

Live Webinar With Merle Capello

Upcoming Webinars