Episode 1: Mastering the 2025 EU-GMP Chapter 4 Draft Update

EU-GMP Chapter 4

Documentation has undergone its most significant revision in over a decade, introducing sweeping changes that impact quality systems, data integrity, and compliance practices across the pharmaceutical industry. This expert-led webinar offers a practical deep dive into the updated guidance, exploring the regulatory drivers behind the changes and what they mean for your SOPs, digital documentation, and audit readiness.

We’ll unpack the new expectations around data governance, metadata traceability, electronic and hybrid systems, and AI accountability - plus, how these align with global efforts to harmonize standards across the FDA, EMA, WHO, MHRA, and PIC/S. With documentation at the heart of nearly 40% of FDA GMP inspection findings, this is your opportunity to strengthen your systems, close compliance gaps, and prepare for the future of regulated recordkeeping.

Whether you work in quality, manufacturing, regulatory affairs, or IT, this session will equip you with the clarity and strategies needed to stay compliant in an increasingly digital, risk-based environment.

Why Attend?

✅ Avoid Costly Deficiencies: Learn how to prevent the most common inspection failures.
✅ Boost Compliance Confidence: Understand what changes matter most and how to apply them.
✅ Future-Proof Your Documentation: Get ahead of digitalization, hybrid systems, and data risks.
✅ Gain Insider Insights: Hear directly from GxP-CC consultants with frontline experience.
✅ Improve Operational Efficiency: Better documentation = fewer errors, smoother audits, and lower costs.