Digitization is transforming regulated industries, but combining Agile flexibility with GxP compliance remains a challenge. Agile methods enable rapid adaptation and incremental delivery, while GxP predictive approaches provide structure, documentation, and regulatory assurance.
In this webinar, we’ll show how a GxP-Hybrid Project Management approach balances these two worlds to enable innovation without compliance risks.
You’ll learn how to:
Apply predictive rigor where compliance is critical (e.g., validation and testing)
- Use Agile methods to add flexibility and value during development
- Integrate checkpoints between Agile and predictive phases to maintain traceability
- Implement lean, auditable documentation and hybrid change control
This session provides practical insights for project managers, quality experts, and IT professionals seeking to deliver regulated projects efficiently while remaining inspection-ready.
AGENDA
Predictive Rigor in GxP Projects
Agile Methods for Flexibility and Value
Integration Checkpoints
Lean Documentation & Hybrid Change Control
ADDITIONAL INFO
When:
Wednesday, September 24, 2025 · 4:00 p.m.
Berlin
Franziska Hartmann is a senior consultant with multiple years of experience in leading validation and qualification projects to success. She specializes in bringing diverse groups together to find common agreements and it is important to her that...
James R. Francum is a highly experienced expert in Life Science Compliance services, with over 20 years of experience in the professional services field. As the CEO of GxP-CC, James leads organizations’ compliance projects, focusing on the most...