Boston Professional Events List


Software Validation for the New FDA Inspections


Date
May 14, 2019 - 01:00 PM - 02:00 PM
Organizer
WCS
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

Hollywood,
FL,
US,
ZIP: 33021
Phone: 844-267-7299 | 954-947-5671  

Overview

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 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. 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.



Session Highlights

  • 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

  • Engineer management

  • Software engineer

  • Programmer

  • Quality assurance

  • Regulatory



Speaker Details


  • Speaker Profile


Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents)


 Wcs Seminars
Registration Details
(Contact us : 844-267-7299 | 954-947-5671  
Don't wait. Register TODAY or  Email  US [email protected]


Event Categories
Keywords: pharmaceutical




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