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WATCH THE FREE WEBINAR: Risk-Based CAPA Under ICH E6(R3)

Webinar

Ask an Expert TMF Office Hours - Culture

Culture plays a critical role in how TMFs are built, maintained, and defended during inspection. Yet it is often the hardest element to define, align, and sustain across teams.

In this Ask an Expert TMF Office Hours session, Laurel-Ann Schrader and Gill Gittens lead an open, interactive discussion focused on TMF culture and what it really looks like in day-to-day operations. Drawing from real-world experience, they explore how culture influences ownership, decision making, communication, and inspection readiness.

This session is designed for honest conversation and practical insight. Attendees are encouraged to bring questions, challenges, and scenarios for live discussion.

Topics include:

What a strong TMF culture looks like in practice

How leadership behaviors shape TMF quality and accountability

Common cultural gaps that lead to inspection findings

Aligning sponsors, CROs, and functional teams around shared expectations

Practical ways to reinforce ownership and confidence across the TMF lifecycle

This office hours session is ideal for TMF leaders, sponsors, and functional team members who want to move beyond process and tools and build a TMF culture that supports control, clarity, and inspection readiness.