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06Nov
Computer System Validation
1:00 PM - 2:00 PM Training Doyens
Date: November 06, 2018 to November 06, 2018
Where: Training Doyens, 26468 E Walker Dr, Aurora, Colorado, United States, 80016
Phone: N/A
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Ticket Price: N/A
OVERVIEW According to the FDA requirements 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). Computer system 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. In this computer system validation training you?ll learn how to integrate risk based supplier evaluation into the computer system validation process. 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. AREAS COVERED ? Computer system validation strategy ? Requirements documentation ? Complexity and risk analysis ? Creating a detailed test plan based on risk ? Supplier qualification ? IQ, OQ and PQ LEARNING OBJECTIVES ? Computer system validation life cycle models and Validation Plan contents ? How to determine the complexity category of your system based on GAMP 5 principles ? Guidelines on 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 WHO WILL BENEFIT ? IT Staff ? Computer System Users ? Quality Assurance ? Regulatory ? System Vendors For more detail please click on this below link: https://bit.ly/2Pl2Ei9 Email: support@trainingdoyens.com Toll Free: +1-888-300-8494 Tel: +1-720-996-1616 Fax: +1-888-909-1882