Quality by Design - New concepts for Chemical and Biotech Product Development and Optimisation
September 22 - 24, 2014 - Vienna CHDIA Europe, Middle East and Africa
diaeurope@diaeurope.org
Phone:+41612255151
Key Topics • Quality by Design for biotech products and small molecules • Prior Knowledge, Knowledge Management and QTPP Development • Initial Risk Assessment (FMEA), Introduction to Process Characterisation and Design of Experiments • Experimental Work, Multi-variate Data Analysis (MVA) and Knowledge Space Establishment • Design Space Definition • Control Strategy • Technologies Assisting QbD Approach • Regulatory Flexibility and QbD submission strategies • Post-Approval Change Management Protocol
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