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Risk Based Computer System Validation

Duration : 60 Minutes

Edwin Waldbusser, Medical Device

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 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 L Read more

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 much 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:

o How to manage the validation process
o Validation life cycle models and Validation Plan contents
o How to determine the complexity category of your system based on GAMP 5 principles
o How to evaluate risk level using GAMP 5 modifications to the ISO 14971 procedure
o What level of testing is necessary based on software complexity and risk
o Integrating software supplier evaluation into the validation process
o What documentation is necessary
o how to minimize documentation to reduce costs based on risk
o How to plan and conduct IQ, OQ and PQ

Course Outline:

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

What You Get:

• Training Materials
•  Live Q&A Session with our Expert
•  Participation Certificate
•  Access to Signup Community (Optional)
•  Reward Points

Who Will Benefit:

• Computer system developers
• Systems development engineers
• Lab Managers and Analysts
• Production Managers
• Engineering managers
• Quality Assurance
• Regulatory Affairs
• Operations
• Engineers
• Quality Engineer
• QA/QC Professionals
• Engineering/Technical Service Professionals
• Consultants
• Operations and Manufacturing
• Compliance Professionals

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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