Results-driven and accomplished professional with over 23 years of expertise in Computer Systems Validation (CSV) and Quality Assurance (QA). Proven track record in orchestrating GxP systems, ensuring regulatory compliance, and driving continuous improvement initiatives. Adept at leading high-performing teams, implementing Agile Methodology, and successfully presenting and defending systems validation during regulatory audits.
Case Study
Thursday, July 18
12:30 pm - 01:00 pm
Live in Singapore
Less Details
How to achieve one global template followed by an agile MES rollout on all sites and to find a way in doing so that is compliant and efficient at the same time. In this session, Esra is going to show us how to start an MES execution with the architecture set-up, rollout methodologies to use and requirements, features and benefits of agile MES validation.
Part 1 – What is a MES?
Part 2 – MES Validation Deliverables
Part 3 – MES Data Integrity and Compliance