Quality culture is one of the most discussed topics in pharmaceutical manufacturing, yet it remains difficult to define, measure, and influence in practice, especially in Germany’s structured, compliance-driven environment with strong data protection expectations. In this session, Iain Rusling, Founder and Managing Director of Alexium Consulting, alongside Angel Buendía, Scilife’s Knowledge Manager, will explore the role of quality leaders in shaping and sustaining a strong quality culture in GMP environments.
You’ll learn:
- How regulators (FDA and EU) assess quality culture during inspections.
- Why weak quality culture leads to recurring deviations and poor investigations.
- How leadership behavior shapes transparency, problem-solving, and decision-making.
- Practical ways to strengthen operational ownership of quality across teams.
