Lyophilization Processes: A Compliance/ Enforcement Perspective

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Lyophilization Processes: A Compliance/ Enforcement Perspective
January 25, 2005
By Anne Johnson
International Society of Lyophilization, Delaware Valley Chapter
Organizational Structure of FDA Compliance
FDA's Regulatory Options/ Enforcement Posture
Specific Examples of Deviations
Written Responses
Dispute Resolutions
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