Training Doyens

OVERVIEW This webinar will take you through the  System Development Life Cycle (SDLC)  approach to  Computer System Validation (CSV) , focusing on the definition, testing, and documentation of functional and other requirements to ensure the system meets FDA compliance. This FDA compliance training will help you understand how the definition of functional and other system requirements fit into the  System Development Life Cycle (SDLC)  approach to  Computer System Validation (CSV) . Getting the requirements right, and ensuring they are comprehensive, is one of the most challenging components of the process. WHY SHOULD YOU ATTEND You should attend this webinar to learn about: Computer System Validation (CSV) approach. Using the System Development Life Cycle (SDLC) methodology to support CSV efforts. CSV and SDLC deliverables that must be documented properly to comply with FDA requirements. A deeper dive into ...

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). Computersystem 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. 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 e...