Navigating safely Annex11
& Annex22 EU GMP Regulatory Changes
On demand webinar
What Will I Learn From This Webinar?
- How Annex 22 Chapter 4 changes affect digital traceability and governance
- Strategies to minimize regulatory risk and avoid non-compliance penalties
- Which systems, including Cloud, SaaS, and AI/ML platforms, are now in scope under the updated guidelines
- How to assess your current systems and identify compliance gaps
Abstract
The upcoming Annex 11 revision is about to change how life sciences businesses interact with computerized systems and digital tools. The updated guidelines, which go beyond traditional GMP systems and cover new and emerging technologies such as Cloud, SaaS platforms, and AI/ML-based solutions, are redefining our understanding of digital compliance.
Working alongside the new Chapter 4 of Annex 22, these changes establish a stronger focus on digital traceability and introduce a new governance model that will impact the life sciences industry for years to come.
If you are curious about what these changes mean for your organization and what actions you must take now to avoid compliance issues after the effective date, make sure you join our exclusive webinar.
Speakers
Danilo Maruccia
Speaker
Principal consultant and Partner
at PQE Group
Thomas Carganico
Moderator
VP of Strategic Development, Marketing
& Communications and Partner at PQE Group