Date:

23. - 24. June 2025

Language:

Location:

The event will be held in German.

Best Western Plus Hotel Cologne City, Germany

and online

Click here to register.

Abstract:

wega is proud to join the Pharma IT Compliance 2025, taking place on June 23–24 in Cologne and online. This high-level conference brings together industry experts, regulators, and technology leaders to discuss the latest developments at the intersection of IT, compliance, and the pharmaceutical sector. Key topics include AI-driven solutions in regulated environments, cloud provider audits, data integrity, cybersecurity, and the evolving regulatory landscape. Our own Christophe Girardey will present on modern approaches in GxP validation, agile frameworks, and testing. The event offers deep insights, practical strategies, and valuable networking opportunities for professionals navigating compliance in a digital age. We look forward to contributing to the dialogue on innovation and regulatory excellence in pharma IT.

 

More details about the event can be found here.

Our Presentation (held by Christophe Girardey):

“Modern” Approaches in GxP: Tools, Framework and Testing

Date: Monday, 23rd of June 2025, 11:45 - 12:30

  • The sad reality of today's validation processes
  • Success factors through “modern” approaches:
    • The use of suitable tools: Record vs. documents
    • Agile project management in GxP
    • Automation of tests
  • The regulatory perspective on modern approaches
    • Annex 11 revision, CSA and others
    • GAMP5 Good Practice Guides

For us on site:

Christophe

Christophe Girardey

Managing Director and Head of the CSV & QA department at wega Informatik AG.

He works as a CSV consulting expert in many different projects, mainly in German-speaking countries.

He has a particular focus on laboratory data systems (LIMS, chromatography data systems, laboratory execution systems) and supports customers in implementing the best solution from various perspectives (efficiency, compliance, data integrity).

He also supports many customers in the optimal use of the agile methodology in the GxP environment.