Computerised System Validation (CSV)
Dr. Eva Kelly discusses 'What is CSV' - looks at definitions that include documented evidence, computerised system, intended use, lifecycle and control, GxP regulations.
Where many fall down is system boundary understanding so she then dives into 'What is a computerised system' - discussing the operating environment not just the software. Example deliverables and risk informed validation approaches are then evaluated during the training session.
Where many fall down is system boundary understanding so she then dives into 'What is a computerised system' - discussing the operating environment not just the software. Example deliverables and risk informed validation approaches are then evaluated during the training session.
This virtual course is designed to be interactive and discuss real life challenges that you may face.
What's Included?
Dr. Eva Kelly
Eva has a degree in Analytical Science and a PhD in Chemistry from Dublin City University. She has over 30 years of site solutions and learning management experience across pharmaceutical, medical device, industrial, veterinary and FMCG sectors.
Eva has worked as a Data Integrity SME specialising in21 CFR Part 11 and Annex 11 compliance and held Data Integrity lead and QA IT lead positions for pharma and biotech companies utilising GxP SAAS, hosted and on-premise solutions. She has been involved with many international DI remediation projects with significant positive outcomes. She continues to support client regulatory audit activities and conducts IT vendor and CxO audits on a regular basis.
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