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CO-LOCATED EVENTS

Speaker

Tina Walther

Advanced MES analyst, Novo Nordisk

1999-2004 Novo Nordisk, QC-lab Laboratory technician, Chemical and biological analysis
2004-2007 Novo Nordisk, Supporter Formulation of insulin products
2007-2010 Novo Nordisk, Special technician, Formulation of insulin products
2011-2012 Novo Nordisk, Special technician, Project coordinator, work package owner for formulation of insulin products
2012-2018 Novo Nordisk, Professional (formulation) Project manager, work package owner for formulation of hGH and hemophilia products.
2018- Novo Nordisk, Advanced MES analyst (PAS-X) in Global Novo Nordisk MES agile program.
Currently part of the Fill & Finish expansions project with focus on standardized and harmonized GMBRs for multiple site deployment.

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Sessions

What Is the Smartest Way to Migrate or Deploy an MES System at Scale Across Multiple Sites While Ensuring Efficiency and Minimizing Risk?

(8) Challenge Your Peers

Monday, September 22

04:30 pm - 05:30 pm

Live in Berlin

Less Details

  • How can you ensure smooth and rapid MES deployment across 25 sites within a short timeline?
  • What are the key challenges in migrating from an existing system to a new MES, and how can they be addressed?
  • How can templates and validation scopes be standardized and shared across different locations during deployment?
  • What strategies should be used to allocate roles and responsibilities effectively during large-scale MES migrations?
  • How can an agile approach to system integration improve the success of MES deployment in a fast-paced environment?
Workshop

How Can Organizations Navigate the Complexities of New Audit Requirements While Keeping SOPs Efficient and Compliant?

(7) SOP Café

Tuesday, September 23

11:00 am - 03:00 pm

Live in Berlin

Less Details

  • What are the most critical changes in audit and inspection requirements from authorities, and how do they affect SOPs?
  • How can organizations handle automatic checks versus manual interventions in audits to ensure compliance with new regulations?
  • What steps should be taken to ensure batch records meet the new authority requirements during an audit?
  • How can companies effectively communicate feedback to authorities regarding the new audit requirements?
  • How should organizations adapt their SOPs to handle non-compliance risks while meeting new audit standards?
Workshop

World Café Harvesting Session

Tuesday, September 23

03:30 pm - 04:05 pm

Live in Berlin

Less Details

In the Harvesting Session the workshop moderators of the event will summarize the results of their discussions and highlight key findings from the World Cafés.

Presentation

Company

Novo Nordisk

We are a global healthcare company, founded in 1923 and headquartered just outside Copenhagen, Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity, and rare blood and rare endocrine diseases. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure the diseases we treat. We employ more than 55,000 people in 80 offices around the world, and market our products in 170 countries.
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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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