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WEBINAR From Guidance to Practice: Navigating Data Integrity Under EU Annex 11, Annex 22 Draft & FDA Regulations

WEBINAR From Guidance to Practice: Navigating Data Integrity Under EU Annex 11, Annex 22 Draft & FDA Regulations

The program spans regulatory interpretation, practical implementation, inspection readiness, and the growing role of AI and Machine Learning in GxP-regulated environments

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Date6th – 6th May 2026
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PlaceCvent Platform, Online
Price
from€349
calendar_month
Date6th – 6th May 2026
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PlaceCvent Platform, Online

The integrity of data generated, processed, and stored within GxP-regulated environments sits at the heart of pharmaceutical compliance. As regulatory frameworks continue to evolve — and as digital transformation accelerates across the industry — organisations face mounting pressure to ensure that every data point created throughout the product lifecycle is attributable, legible, contemporaneous, original, and accurate (ALCOA+).

This three-session webinar series, From Guidance to Practice, is designed to bridge the gap between regulatory text and real-world implementation. Drawing on the requirements of EU Annex 11 (Computerised Systems), the newly drafted EU Annex 22 (Management of Data and Records), and the FDA's evolving guidance on data integrity and computer software assurance, the programme offers practitioners a structured, expert-led pathway through the regulatory landscape.

Speakers

Marta Rodríguez Vélez, ES
Marta Rodríguez Vélez, ESStrategic Planning and Operational Excellence ManagerLETI Pharma
Karolina Rokita Woodford, CH
Karolina Rokita Woodford, CHSenior CQV CAPEX Project EngineerLonza Visp
Kees Mensch, NL
Kees Mensch, NLCo-Founder @ The Digital Capability Company | Leading Digital TransformationsThe Digital Capability Company

Key points

  • Explain the current requirements under EU Annex 11

  • Describe the key changes introduced by the Annex 22 Draft

  • Compare FDA guidance on data integrity against EU frameworks

  • Highlight compliance implications for industry

  • Define ALCOA+ and map principles to regulatory expectations

  • Demonstrate practical implementation in computerised systems

  • Address hybrid environment challenges

  • Share real-world examples of data integrity failures and preventive strategies

  • Understand how AI and automation can proactively identify data integrity risks

  • Evaluate the key validation requirements for AI monitoring tools in GxP

  • Design governance frameworks for AI-powered continuous monitoring

  • Assess tool options and approaches for anomaly detection in audit trails and data flows

Who should attend

Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specializing in:

  • Quality Assurance & Quality Systems Managers
  • Regulatory Affairs Professionals
  • IT, CSV & Computer System Validation Specialists
  • Compliance Officers & GxP Auditors
  • Manufacturing & Operations Leaders
  • Data Scientists & Digital Transformation Teams
  • Senior Leaders & Heads of Quality / Compliance

WEBINAR From Guidance to Practice: Navigating Data Integrity Under EU Annex 11, Annex 22 Draft & FDA Regulations

The program spans regulatory interpretation, practical implementation, inspection readiness, and the growing role of AI and Machine Learning in GxP-regulated environments

calendar_month
Date6th – 6th May 2026
map
PlaceCvent Platform, Online
Price
from€349

FAQ

Your questions answered here.

How can I access the webinar?

The webinar is streamed exclusively through the Cvent platform. Registered attendees will receive a secure link to join. 

What packages are available?

  • STANDARD – Webinar access + digital certificate of attendance.

  • ALL IN ONE – Webinar access + recording + digital certificate of attendance.

  • RECORDING ONLY – Access to the webinar recording via a secure link.

Will I get a certificate of attendance?

Yes. All in One & Standard packages include attendance provide a digital certificate.

What language will the summit be conducted in?

All summit sessions will be presented in English. While translation services are not provided, we welcome attendees from around the world and encourage everyone to join the discussions and networking opportunities.

For any event assistance please contact

Gabriela Rychtářová
Gabriela RychtářováSales & Marketing Manager
mailgabriela@etapahub.comcall+420 777 717 488