Process Scale-Up & QbD Principles in Pharma

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PROGRAM

Day 1

29 September

Session 1: Application of Quality by Design Principles During Process Development and Scale-Up (part I)
Session 2: Application of Quality by Design Principles During Process Development and Scale-Up (part II)
Session 3: Scale-Up, Registration and Process validation for NCEs
Session 4: Scale-Up of the Compaction and Tableting Process

Day 2

30 September

Session 1: Introduction to Biologics and parenteral drug products
Session 2: Formulation and Drug Product Development
Session 3: Process development – “Liquid vs Freeze Dried” upscale and transfer
Session 4: Control Strategy and Validation (PPQ and more)