Scilife Smart
Quality Summit 2025

'The human element in any system is always prone to error. But in QA, not all nonconformities can be blamed on human error. In this talk, you’ll learn how to write clear problem statements, involve management to define clear rules for when corrective action is necessary, engage the right stakeholders early, and use project management skills to keep CAPAs on track… all without finger-pointing.

Let’s challenge the checkbox mindset and explore how MedTech teams can embed quality into their organization’s DNA. Drawing from real-world consulting experience, we’ll outline the shift from reactive to proactive quality management, including tools, structures and mindset changes to drive real impact. You’ll get a practical framework for a lean, scalable QMS and know how to link quality outcomes to commercial success.

Are you a QA/QC professional looking for fresh strategies to navigate risk in today’s fast-paced landscape? In this session, we’ll draw on ICH Q9 and real-world, cross-sector scenarios to show how QRM principles can be applied with clarity, intention, and measurable impact. Join us to gain actionable insights into strengthening your risk assessments, decision-making and communication to drive better outcomes across GxP environments.

In an industry where transparency is rising, embedding and measuring quality culture is becoming essential. It begins with a shared understanding of what “quality” really means, distinguishing between big-C Culture and small-c culture: the daily habits that turn strategy into action. To align both, organizations can use practical KPIs to assess maturity, track progress, and unlock long-term growth.

Despite being central to compliance and operational excellence, QA professionals often feel unheard, siloed, and seen as blockers rather than enablers. In this roundtable, two industry KOLs and a seasoned QA leader will share real-world experiences and practical strategies for making quality visible, relatable, and impossible to ignore. From overcoming resistance and building trust, to adapting messages for different stakeholders, you’ll gain fresh perspectives and actionable insights into strengthening collaboration across functions and influencing decision-making with credibility and clarity.