Case Study
Monday, September 25
11:30 AM - 12:00 PM
Live in Berlin
Less Details
Apotex is putting multiple sites in one global MES paperless EBR system to create fast workflows, loose paper recipes completely and discuss best practice validation approaches and its requirements. The goal is 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 her talk 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 paperless and agile MES validation.
This presentation covers:
Ms. Guven over 20 years of experience in IT Quality and Computer Systems Validation in Pharmaceutical Industry at Apotex including: Process / Continuous Improvement experience, superior knowledge on FDA 21 CFR Part 11 Electronic Records and Electronic Signatures and Data integrity remediation.
Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 10,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development.
Continuous learning and improvement is a driver in my job. The technology is changing and very dynamic. I love my job as adapting new methods and technologies into Computer Systems Validation excites me.