Pre-Approval Inspection Readiness for Pharma Manufacturers and Sponsors

Presented on Wednesday, November 5, 2025

Download our webinar with Diana Aberion, Sr. Director of Audits and Inspection Management at Gilead Sciences, and Yelena Ionova, Senior Manager of Data Strategy and Analytics at Redica Systems, for a data-driven look at how manufacturers and sponsors can prepare effectively for Pre-Approval Inspections (PAIs) / Pre-License Inspections (PLIs).

Gain insight into how regulatory agencies determine inspection priorities, what differentiates PAI/PLI from routine inspections, and how to design a staged readiness approach that reduces risk across your supply chain.

Key Insights:

• Anticipate Inspection Risk with Data – Discover how to use FDA inspection trends and risk indicators to predict when and where a PAI or PLI is most likely—and focus your readiness efforts accordingly.
• Build a Smarter, Staged Readiness Plan – Learn how leading sponsors and CMOs structure phased inspection readiness across sites and partners to align GMP, commercial, and product milestones for approval success.
• Avoid the Quality System and Data Integrity Pitfalls That Derail Approvals – See what the latest inspection data reveal about the most common causes of CRLs and how to benchmark your organization’s readiness against top industry performers.