Software Validation for the New FDA Inspections

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 60 Min Live Webinar

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

Methods to execute necessary testing

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.

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

•         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

Industries who can attend

This 60-minute online course is intended for professionals in the All industries and companies


Speaker Profile

Edwin Waldbusser

Edwin Waldbusser retired from industry after 20 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. 

His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/control and manufacturing/non-conforming product programs.

Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.

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