GCP Inspection Insights - March 26 | 11-2:30 PM ET
Real-World Insights to Help Anticipate Risk and Stay Inspection-Prepared
Inspections are evolving — and the signals are becoming more visible.
GCP Inspection Insights brings together experienced clinical quality and operations leaders for an honest look at how inspections are actually unfolding today. With a deliberate focus on FDA-driven transparency trends, real inspection data, and firsthand perspectives across regulatory authorities, this program goes beyond guidance to examine what to anticipate, adjust, and prioritize to remain inspection-ready.
What You'll Learn:
- How regulatory and political shifts are influencing inspection strategy and enforcement
- What increased FDA transparency means for oversight, risk management, and accountability
- How inspection data and analytics can reveal readiness gaps earlier
- What regulatory investigators are asking during inspections today
- Where inspection expectations are converging across global regulatory authorities
Featured Sessions
SCIENCE UNDER PRESSURE—Preparing Your Inspection Readiness Strategy Amid Regulatory and Political Change
Melissa Cabuang, Senior Director, Quality Assurance Program Head, GENENTECH
FDA TRANSPARENCY IN PRACTICE—What Increased Inspection Visibility Means for Your Risk, Oversight, and Accountability
Niloy N. Shah, Vice President, R&D Quality, REPLIMUNE
EXPERT PANEL: INSIDE TODAY’S GCP INSPECTIONS
What Regulatory Investigators Are Asking Now, and What’s Catching Even Experienced Teams Off Guard
Panelists
Shola Jhanji, Associate Director/Quality Program Lead, GENENTECH
Samalyse Lees, Senior Quality Advisor, GSK