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U.S. Department of Health and Human Services

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Joint EU/FDA/PDA/ISPE Training on ICH Q10 Pharmaceutical Quality Systems – Presentations (Days 1 & 2)

 

                        

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Joint EU/FDA/PDA/ISPE Training on ICH Q10 Pharmaceutical Quality Systems-Agendas

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Introduction to PQS, Transforming Quality Culture, and the Business Case

Day 1 (Plenary 1 and 2: Pharmaceutical Quality Systems)

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Regulatory Perspectives on Quality Systems

Day 1 (Plenary 1 and 2: Pharmaceutical Quality Systems)

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Management Responsibility For The Supply Chain (Contract Operations And Purchased Materials)

Day 1 (Plenary 3 and 4: Management Responsibility) (Cont'd)

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The Process Performance and Product Quality Monitoring System

Day 2 (Plenary 8: Pharmaceutical Quality System Elements: Process Performance and Product Quality Monitoring System)

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