eSeminar: How to efficiently and cost-effectively execute Computer Systems Validation (CSV)

6. 5. 2020


During this webinar you will learn about Compliance Consulting services that are available from Agilent Technologies and our team of Compliance Specialists that are available to assist you with your daily compliance challenges. Computer System Validation (CSV) is a hot topic for Regulatory Inspectors so we will be discussing the need to perform this activity in order to defend that your GxP software has been correctly configured and validated based on your Intended Use. Greg has been working at Agilent for 1 ½ years, prior to Agilent he spent 14 years working in the Pharma Industry and GMP environments. During his time working in Pharma, he spent 10 years performing Computerized System Validation activities on Enterprise and standalone computerised systems and worked on a number of Data Integrity remediation projects. he also has experience with FDA local regulatory and customer audits. When he joint Agilent, he initially worked in the IES EMEAI team performing Enterprise OpenLab CDS Installations and ACE qualifications. He is currently working in the European Compliance Consulting team managing compliance consulting projects focused on Computerized System Validation (GAMP 5 methodology) and Data Integrity assessment/remediation. He works with the Global Senior Compliance Consultant to provide customer specific compliance services to meet the customer’s requirements which include: Computerized System Validation, Audits/Assessments, custom AIQ procedure development, and Data Integrity assessments and remediation. Therese Heffernan is the European Compliance Consultant for Agilent Technologies. Therese has over 20 years of experience working in Regulated Pharmaceutical Industry prior to joining Agilent in 2019. During this time she has been involved in the design build and qualificaion of 2 green site laboratories, managed routine testing laboratories and worked on data integrity remedations for the site, while support regulatory audits. Therese’s role within Agilent as a Compliance Consultant is to help delivery Compliance to customers and a compliance manager, including the generation of computer system validation (CSV) documentation and ensuring the customer understands how the software will meet their intended use.

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