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
ANALYTICS CASE STUDY — How Data-Driven Insights Shift GCP Inspection Readiness from Reactive to Risk-Proportionate
Sofija Krivokapić
Data Science Lad, Clinical Quality
ASTRAZENECA
Data Science Lad, Clinical Quality
ASTRAZENECA
EXPERT PANEL — INSIDE TODAY’S GCP INSPECTIONS
What Regulatory Investigators Are Asking Now, and What’s Catching Even Experienced Teams Off Guard
Moderator
Donna Dorozinsky
Founder & CEO
JUST IN TIME GCP
Founder & CEO
JUST IN TIME GCP
Panelists
Shola Jhanji
Associate Director/Quality Program Lead
GENENTECH
Shola Jhanji
Associate Director/Quality Program Lead
GENENTECH
Director, Inspection and Intelligence Lead
GSK
Sarah Silvers
Head of Clinical Quality Assurance
ORCA BIO
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