Risk Based Computer System Validation What You Need to Know To Comply with FDA Requirements

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

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

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

How to integrate risk based supplier evaluation into the validation process

Description

FDA requires that all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than validation of device software (embedded software). Validation is more than testing. It is testing plus design control and configuration management.

How to plan and conduct a risk based validation will be explained. Overall risk for computer system is a combination of software complexity and product risk as determined by probability, severity and detectability rankings. Also involved in the risk evaluation is the requirement for purchased software supplier qualification. You’ll learn how to integrate risk based supplier evaluation into the validation process.

Validation Master plan and System Validation Plans will be explained

Testing, based on risk, includes requirements validation and IQ, OQ and PQ. A procedure for each level of complexity and risk will be described.

Why should you Attend

Validation of computer system software is completely different than validation of device software (embedded software). Attempting to conduct a CSV following device software validation concepts could result in a 483 or rejection of a product approval submission.

Validation life cycle models and Validation Plan contents

How to determine the complexity category of your system based on GAMP 5 principles

How to evaluate risk level using GAMP 5 modifications to the ISO 14971 procedure

What level of testing is necessary based on software complexity and risk

Integrating software supplier evaluation into the validation process

What requirements documentation is necessary

How to plan and conduct IQ, OQ and PQ

Areas Covered

•         Validation strategy
•         Requirements documentation
•         Complexity and risk analysis
•         Creating a detailed test plan based on risk
•         Supplier qualification
•         IQ, OQ and PQ

Who will Benefit

•         Computer system developers
•         Systems development engineers
•         QA/ QC
•         Lab Managers and Analysts
•         Production Managers
•         Engineering managers

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


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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