Advance Your Lab Operation: Real Life Challenges and Solutuins seen with CSV Projects

During this webinar we will run through the real challenges that customers face when performing CSV and how Agilent has helped customers by linking their needs to the capabilities of the application being validated. We will also look at how Agilent's compliance consulting services and the continuous improvement of our own starter kits can reduce the time and burden CSV causes to the customer.

Greg Shaw (European Compliance Consultant, Agilent Technologies)

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.

Thérèse Heffernan (European Compliance Consultant, Agilent Technologies)

Thérèse Heffernan is a European Compliance Consultant for Agilent Technologies and a member of Agilent's Compliance Council. Therese has 20 years of experience working in Regulated Pharmaceutical Industry prior to joining Agilent in 2019. During this time she has been involved in managing compliance consulting projects focused on Computerized System Validation (GAMP 5 methodology) and in the development and delivery of Agilents new CSV Starter Kits. She 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.