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 15: Drug Master File Interactive Workshop

Session Chair(s)

Priya Jambhekar

President

PBS Regulatroy Consulting Group, United States

Session 15: Drug Master File Interactive Workshop

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

Session 15: Drug Master File Interactive Workshop

Session Chair(s)

Priya Jambhekar

Be informed and stay engaged.