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DIA Global Center

2017 年 09 月 11 日 8:15 上午 - 2017 年 09 月 12 日 3:30 下午

21 Dupont Circle NW, Suite 300, Washington, DC 20036

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

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Session 24: FDA Enforcement Actions: Form FDA 483 and Warning Letters

Session Chair(s)

Albert S. Yehaskel, MBA

Albert S. Yehaskel, MBA

President and CEO

Refuah Global Pharmaceutical Development, Inc., 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