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

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

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Session 21: FDA Enforcement Actions - Form FDA 483 & Warning Letters

Session Chair(s)

Priya Jambhekar

President

PBS Regulatroy Consulting Group, United States

Types of Enforcement Actions
FDA Inspections and Inspection Documents
Form FDA 482, 483, and 484
Warning Letters
Addressing a Warning Letter
cGMP Deviations