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.
Expert Speakers
- Melissa Cabuang, Senior Director, Quality Assurance Program Head, GENENTECH
- Donna Dorozinsky, Founder & CEO, JUST IN TIME GCP
- Shola Jhanji, Associate Director/Quality Program Lead, GENENTECH
- Sofija Krivokapić, Data Science Lead, Clinical Quality, ASTRAZENECA
- Samalyse Lees, Senior Quality Advisor, GSK
- Niloy N. Shah, Vice President, R&D Quality, REPLIMUNE
- 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
Session Topics
SCIENCE UNDER PRESSURE
Preparing Your Inspection Readiness Strategy Amid Regulatory and Political Change
FDA TRANSPARENCY IN PRACTICE
What Increased Inspection Visibility Means for Your Risk, Oversight, and Accountability
ANALYTICS CASE STUDY
How Data-Driven Insights Shift GCP Inspection Readiness from Reactive to Risk-Proportionate
EXPERT PANEL: INSIDE TODAY’S GCP INSPECTIONS
What Regulatory Investigators Are Asking Now, and What’s Catching Even Experienced Teams Off Guard