Webinar Duration: 60 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Edwin Waldbusser
OVERVIEW:
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.
You will learn in detail:
– 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 in the Session:
– 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
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. Mr. Waldbusser has a BS 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.
