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
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
• 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