Learning Tracks

This session will examine opportunities to strengthen alignment between OII and CDER and streamline pre-approval inspection decision-making, particularly for mature, low-risk facilities. Panelists will discuss risk-based approaches to inspection planning, earlier communication regarding inspection readiness, clearer criteria for when pre-approval inspections may be waived or deferred, expanded use of remote or hybrid assessment tools, and better integration of facility-level quality and compliance history into inspection triggers. The discussion will focus on practical steps to reduce approval delays while maintaining robust oversight of manufacturing quality.

Brian Folian, MS, JD
Deputy Office Director, IO, OSIS, OTS, CDER, FDA

Yiwei Li, PhD
Supervisor, OPMA, OPQ, CDER, FDA

Justin Mann, JD
Associate General Counsel, Global Regulatory Compliance, Teva Pharmaceuticals

Piyush Modi
Director, Regulatory Affairs, Amneal Pharmaceuticals

Bhupesh Singh, MPharm
Director, Regulatory Strategies and Labeling, Apotex Corp.