Event Date/Time: Jul 24, 2007 End Date/Time: Jul 26, 2007
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Description

FDA Keynote Address:
FDA's Pharmaceutical Quality Assessment in the 21st Century- A Modern Risk-Based Approach

Moheb Nasr, Ph.D., Director, Office of New Drug Quality Assessment, CDER, FDA

1-Lean Design and Development: Applications on ALL Levels from R&D through Manufacturing including Six Sigma, Validation, Formulation Development, Clinical Supply Manufacturing, Pharmaceutical Processes, and Manufacturing Product Lines

2-Pharmaceutical Quality Initiatives in the 21st Century: Quality by Design (QbD), ICH Q8, ICH Q9, Quality Systems, Process Analytical Technology (PAT), Design of Experiments (DOE), and Risk Assessment

3-Cutting Edge Technology: PAT, Ultra Performance Liquid Chromatography (UPLC), ScnaRDI, Laser Induced Breakdown Technology (LIBS), Data Automation, Mathematical Modeling, and Process Transfer

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