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CO-LOCATED EVENTS

Speaker

Esra Guven

Associate Director, Computer Systems Validation, Apotex

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.

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Session

MES Validation and Data Integrity

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? 

  • Define and understand MES? 
  • Benefits of MES
  • Understanding Batch Records
  • MES Enterprise Architecture and Components ​

Part 2 – MES Validation Deliverables

  • MES Requirements Specifications
  • MES Implementation Roll out Strategy
  • MES Agile Deployment and Validation
  • MES Agile Validation Deliverables

Part 3 – MES Data Integrity and Compliance

Presentation

Company

Apotex

Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 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; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties.
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Colocated with
Industry of Things Asia 2024 is part of the Event Series. You can find more events here.
Date
July 17 – 19, 2024
Location
Marina Bay Sands Expo & Convention Center
10 Bayfront Ave
018956 Singapore
Phone
+49 (0)30 52 10 70 3 0
eMail
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