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CO-LOCATED EVENTS

Speaker

Amellalih Reza

Global QA Manager IT Projects, Bayer AG

With over 20 years of experience in pharmaceutical manufacturing, IT systems, and quality assurance, Allelalih has driven digital transformation and regulatory compliance at Bayer and beyond.

As Global QA Manager for IT Projects at Bayer (Schweiz) AG, Allelalih oversees MES, Historian, and BES systems, developing lean validation strategies and ensuring compliance with global standards like FDA and WHO. Previously, he led Data Integrity initiatives at Bayer de México, managing IT infrastructure and streamlining validation processes for consistent global compliance.

Through roles in validation and engineering, Allelalih has consistently bridged technical solutions with business needs, enhancing manufacturing, quality, and engineering processes.

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Session

Revolutionizing MES Validation in Pharma — Achieving Consistency, Efficiency & Compliance

Case Study

Monday, September 22

11:25 am - 11:55 am

Live in Berlin

Less Details

The validation process in MES (Manufacturing Execution Systems) for pharmaceutical manufacturing often poses significant challenges due to the complex interplay between global standards and local site-specific requirements. This session will delve into the development and implementation of a global MES validation model that reduced validation errors by 60%. The approach integrates standardized functionalities, global risk assessments, and local connectivity to achieve seamless integration with site-specific equipment. Explore how leveraging a core system with proven global configurations minimizes redundancy, optimizes processes, and ensures regulatory compliance. In this session, you will learn how to:

  • Implement a global MES validation model to reduce errors and streamline processes.
  • Optimize validation by leveraging standardized configurations and global risk assessments.
  • Ensure seamless local connectivity with site-specific equipment while maintaining global consistency.
  • Minimize repetitive testing efforts through proven global functionalities.
  • Balance global standardization with independent site-by-site adaptability for effective operations.
Presentation

Company

Bayer AG

Bayer is a global enterprise with core competencies in the life science fields of healthcare and nutrition. We design our products and services to serve the most essential human needs of health and nutrition. At the same time, we strive to address some of the world’s biggest challenges presented by a growing and aging global population. At Bayer, we’re committed to driving sustainable development and generate a positive impact with our businesses. Through the power of science, we’re pioneering new possibilities that advance life for all of us. That means reimagining how we care for ourselves and one another by empowering everyday health, improving approaches to patient care, and finding better ways to nourish our communities around the world.
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Colocated with
Pharma Maintenance Europe 2025 is part of the Smart Manufacturing & Industry 4.0 Event Series. You can find more events here.
Date
September 22 – 23, 2025
Location
Maritim proArte Hotel
Friedrichstraße 151, Dorotheenstraße 65
10117 Berlin
Phone
+49 (0)30 52 10 70 3 0
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