Paula R. Katz

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Paula R. Katz, acting branch chief for Regulatory Policy and Collaboration, US FDA, CDER/Office of Compliance/Office of Manufacturing and Product Quality.

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Deficiencies Found in API Inspections

Carmelo Rosa;Paula R. Katz;Alicia Mozzachio
December 2nd 2013

PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.

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Deficiencies Discovered in API Inspections Suggest Strategies for Improvement

Carmelo Rosa;Paula R. Katz;Alicia Mozzachio
December 2nd 2013

PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.

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