WEBINAR OPENS IN
  • DAYS
  • HOURS
  • MIN
  • SEC
ABOUT THIS WEBINAR
The long-awaited update to EU-GMP Annex 11 is here - and it’s more than just a refresh. With the draft released in July 2025, this revision reflects the major shifts in digital technology, regulatory expectations, and risk-based compliance.

From AI accountability to SaaS oversight and immutable audit trails, the updated Annex introduces 17 structured sections that redefine how computerized systems are managed in GxP environments.

In this live webinar, our experts will break down what’s new, what’s changed, and how you can align your systems, SOPs, and validation strategies with the future of compliance.

Why Attend?

✅ Understand the key changes in the 2025 Annex 11 draft
✅ Identify areas in your SOPs that may require updates
✅ Prepare for inspections with greater confidence and clarity
AGENDA
  • Introduction & Context
  • Annex 11 in Transition | Why Annex 11 matters in 2025, From 2011 to 2025: What’s changed and why
  • Key structural and content shifts
  • Practical Implications | What to revisit in your SOPs, Preparing for inspection-readiness
  • Live Q&A with our Experts
ADDITIONAL INFO
  • When: Berlin
  • Duration: 1 hour
  • Price: Free
  • Language: English
  • Who can attend? Everyone
  • Dial-in available? (listen only): Not available.
FEATURED PRESENTERS
  • 1678717378-522f93d5a11bbeb6

    GxP-CC

    Tame Compliance, Avoid Penalties, & Trim Costs
    Get the Customized GxP Compliance Strategy You Need In the Pharmaceutical, Medical and Dental Industries
    Full Profile
  • Webinar hosting presenter

    Dr. Deepthi Ashokkumar

    Consultant
    Deepthi Ashokkumar holds a PhD from TU Dresden, where she specialized in developmental biology and epigenetics. Her expertise includes molecular biology techniques, experimental design, and data analysis. Deepthi also has valuable industry...
    Full Profile
  • Webinar hosting presenter Dr. Elham Abdollahi Mirzanagh

    Dr. Elham Abdollahi-Mirzanagh

    Consultant
    Elham is an experienced consultant in Computer System Validation and Data Integrity in pharmaceutical industry. More, Elham supported data integrity assessment project in a top-level IT supplier for cloud solutions for clinical trials data. She...
    Full Profile
  • Webinar hosting presenter Justo Espinosa

    Justo Espinosa

    Partner
    Justo J. Espinosa is the Operations Officer at GxP-CC, with over 17 years of experience in the consulting industry. Before entering the private sector, Justo spent 10 years in the US Government service.

    Justo’s career in consulting began over...
    Full Profile
HOSTED BY
Share
To invite people, share this page:
COPY
Recommended
More from GxP-CC Webinars →
Powered by BigMarker