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ABOUT THIS WEBINAR
From draft requirements to practical implementation

The draft revision of EU GMP Annex 11 introduces significant changes that impact how computerized systems are designed, operated, and maintained in regulated GxP environments. This session focuses on translating the updated regulatory expectations into practical, risk-based actions that can be applied across the system lifecycle.

The webinar addresses both long-standing Annex 11 topics and new or expanded focus areas, including supplier oversight, security, and audit trail review. Special attention is given to areas that are likely to receive increased scrutiny during inspections.

This session is designed for professionals who are responsible for, or involved in, the governance, validation, and operation of computerized systems and who need a clear understanding of how to prepare for implementation of the revised Annex 11.

Format:

- 90 minutes of focused expert content
- 30 minutes live Q&A for organization-specific questions

Who Should Attend

- Quality Assurance (QA) professionals
- Computer System Validation (CSV) specialists
- IT professionals working in regulated environments
- Compliance and regulatory affairs professionals
- No programming or technical development background is required.

What’s Included

- Live access to the session
- Recording available after the event
- Presentation materials and handouts
- Practical guidance applicable to real GxP systems
AGENDA
  • Structure and principles of the new Annex 11 draft
  • Key changes compared to the current Annex 11
  • Third-party and supplier management expectations
  • Security as a dedicated regulatory focus area
  • Audit trails and audit trail review requirements
  • Practical preparation for implementation and inspection readiness
ADDITIONAL INFO
  • When: Berlin
  • Duration: 2 hours
  • Price: Free
  • Language: English
  • Who can attend? Anyone with the event link can attend
  • 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 Ulrich Köllisch

    Ulrich Koellisch

    Partner
    Dr. Ulrich Köllisch is a partner in GxP-CC and his expertise lies in Life Science Compliance and particular specialization in Data Integrity and Audits. He runs the GxP-CC compliance Academy bringing the brightest minds from Academia into...
    Full Profile
  • Webinar hosting presenter Sangeetha Venkataraman

    Dr. Sangeetha Venkataraman

    Senior Consultant
    Dr. Sangeetha Venkataraman specializes in Computer System Validation (CSV) and Data Integrity, delivering risk-based solutions that enhance quality compliance and operational efficiency in the Life Sciences industry. She collaborates with...
    Full Profile
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