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Clinical research / Pharmacology / United States Public Health Service / Quality by Design / Quality management system / Center for Drug Evaluation and Research / Regulatory compliance / Pharmaceutical sciences / Quality / Food and Drug Administration


ICH Q9 - Regulatory Perspective
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Document Date: 2012-06-22 04:06:42

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File Size: 360,72 KB

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City

Beijing / /

Company

Lifecycle Research Preclinical Phase Clinical Phases Launch Manufacturing / Q9 Design Process Materials Facilities Manufacturing Distribution / Q9 / /

Country

China / United States / /

Facility

facility Robustness / /

IndustryTerm

risk using quality risk management / manufacturing efficiency / quality risk management / /

Organization

Regulatory Perspective Joseph C. Famulare Deputy Director office of Compliance / CDER office of Compliance BACKGROUND Goal / FDA / Food and Drug Administration Center for Drug Evaluation / Research Office / CDER office of Compliance Objectives / CDER office of Compliance GUIDELINE Q9 Contents / CDER office of Compliance BACKGROUND What / CDER Office / CDER office of Compliance GUIDELINE / /

Person

Joseph C. Famulare / /

Position

General Quality Risk Management Process Risk Management Methodology Annex / /

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