GCP Inspection Insights
Where Inspection Reality Meets Readiness
GCP INSPECTION INSIGHTS
Real-World Insights to Help Clinical Research Professionals Anticipate Risk and Stay Inspection-Prepared
Thursday, March 26, 2026 | 11 AM - 2:30 PM ET
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 sponsors need to anticipate, adjust, and prioritize to remain inspection-ready.
Featured Sessions
SCIENCE UNDER PRESSURE — Preparing Your Inspection Readiness Strategy Amid Regulatory and Political Change
Melissa Cabuang
Senior Director, Quality Assurance Program Head
GENENTECH
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
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
What Regulatory Investigators Are Asking Now, and What’s Catching Even Experienced Teams Off Guard
Panelists
Shola Jhanji
Associate Director/Quality Program Lead
GENENTECH
Shola Jhanji
Associate Director/Quality Program Lead
GENENTECH
Director, Inspection and Intelligence Lead
GSK
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
KH ConferencesOrganizer of GCP Inspection Insights