EU GMP Chapter 1 Update: Risk, Knowledge & the Future of the Pharmaceutical Quality System

ABOUT THIS WEBINAR
The recent EU GMP updates have generated significant discussion - particularly the revisions to Chapter 4 (Documentation) and Annex 11 (Computerized Systems).

However, another important update has received less attention:
The modernization of Chapter 1 (Pharmaceutical Quality System).

The revision aims to align the EU GMPs more closely with the current versions of ICH Q9 (R1) and ICH Q10, reinforcing proactive risk management, data-driven decision-making, and knowledge management within the PQS.

We will also share insights from our involvement in industry commenting activities (PDA) and discuss how these changes may influence inspection expectations and PQS maturity assessments going forward.

The session will conclude with an open Q&A discussion.
AGENDA
  • The strengthened emphasis on proactive Quality Risk Management under ICH Q9 (R1)
  • Increased expectations for data-driven decision making and knowledge management
  • The introduction of product availability as a risk factor within the PQS
  • Areas where the update may not go far enough — particularly the continued separation of Data Governance, which remains embedded in Chapter 4 rather than positioned as a core PQS pillar
ADDITIONAL INFO
  • Duration: 45 minutes
  • 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
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  • Webinar hosting presenter Abubakar

    Abubakar Muhammad

    Consultant
    Abubakar is a Consultant at GxP-CC. He studied Molecular Biology at LMU Munich and brings a strong background in quality, regulatory compliance, and project management. He supports clients in solving complex compliance challenges and in developing...
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  • 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...
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