APAS - Automated Plate Assessment System

How software requirements are used in validation - Webinar

2018, January 30

Clinical, Food, Other, Pharmaceutical » Webinar

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.

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

Who Will Benefit:
Engineer Management
Software Engineer
Quality Assurance

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 US and internationally in the areas of design control, risk analysis and software validation for the past 8 years.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com


Internet - webinar


Phone: +1-800-447-9407
Email: support@compliance4All.com
Visit organizer website

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