Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process

This interactive virtual training course will demonstrate CMC sections of regulatory submissions, the FDA inspection process, and how to avoid or minimize 483s (noncompliance) using real-life scenarios.

Back to Agenda

Session 22: Changes Reportable in an Annual Report

Session Chair(s)

Priya Jambhekar

President

PBS Regulatroy Consulting Group, United States

Components and Composition
Manufacturing Sites and Process
Specifications
Container/Closure System