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.

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Session 9: Drug Master Files (DMF)

Session Chair(s)

Priya Jambhekar

President

PBS Regulatroy Consulting Group, United States

Regulatory Basis
DMF Submissions
Transmittal Letter
Administrative Information
FDA Review of DMFs
Types I, II, III, IV, and V DMFs
General Suggestions
Letters of Authorization
Holder Obligations
Transfer of Ownership and Potential Issues

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

Session 9: Drug Master Files (DMF)

Session Chair(s)

Priya Jambhekar

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