Episode 1 - Applying EU GMP Chapter 4

Documentation, Records & Data Governance in Practice

This live webinar focuses on the new EU GMP Chapter 4 draft and its impact on documentation, records, and data governance in GxP environments.

Participants will gain a clear understanding of the most significant changes compared to the current Chapter 4 and how these changes affect both paper-based and electronic records, including hybrid systems. The session addresses how organizations can establish and maintain compliant documentation systems that support data integrity, traceability, and inspection readiness.

Special attention is given to the interaction between Chapter 4 and Annex 11, clarifying expectations where documentation, data, and computerized systems overlap.

The session is designed for professionals responsible for quality documentation, records management, data governance, and compliance oversight.

Format:
90 minutes live content + 30 minutes interactive Q&A
Recording, handouts, and a Chapter 4 gap assessment template included