Overview of Freeze Drying -- Characterization and Determination of Freeze Drying Properties of Frozen Formulations - Case Studies -- Beyond pH: Acid/base relationships in frozen and freeze-dried pharmaceuticals -- Concepts and Strategies in the Design of Formulation for Freeze Drying -- Formulation Design for Freeze Drying - Case studies of Stabilization of Proteins -- Challenges and Considerations in the Development of a High Protein Concentration Lyophilized Drug Product -- Freeze-drying of thermosensible pharmaceuticals with organic co-solvent + water formulations -- Primary container closure system selection for lyophilized drug products -- Vial Breakage During Lyophilization -- The Nucleation of Ice -- Stresses, Stabilization, and Recent Insights in Freezing of Biologics -- Lyophilization Process Understanding and Scale-up using ab initio Vial Heat Transfer Modeling -- Secondary drying: Challenges and Considerations -- Design and Process Considerationsin Spray Freeze Drying -- LyoPRONTO: Deterministic and Probabilistic Modeling. Tutorial and Case Study -- Utilizing Solid-State NMR Spectroscopy to Assess Properties of Lyophilized Formulations -- Design of Moisture Studies for a Lyophilized Product -- Laser-Based Headspace Moisture Analysis for Rapid Nondestructive Moisture Determination of Lyophilized Products -- Application of PAT in Real-time Monitoring and Controlling of Lyophilization Process -- Process Analytical Technology (PAT) for Lyophilization Process Monitoring and End Point Detection -- Advances in Process Analytical Technology - A Small Scale Freeze-Dryer for Process Analysis, Optimization, and Transfer -- Overview of Heat and Mass Transfer Modeling in Lyophilization to Create Design Spaces and Improve Process Analytical Tool (PAT) Capability -- Application of QbD elements in the Development and Manufacturing of a Lyophilized product -- Characterization of Freeze Dryer -- Scale-up and Technology Transfer of a Lyophilization Process -- Lyophilization Validation: Process Design and Modeling -- Lyophilization Validation: Process Qualification and Continued Process Verification -- Homogeneity Assessment of Lyohilized Biological Drug Products During Process Performance Qualification -- Informed Manufacturing through the use of Big Data Analytics for Freeze Drying Process & Equipment -- Multivariate Analysis for Process Understanding, Continuous Process Verification and Condition Monitoring of Lyophilization Processes -- Lyophilized Drug Product Cake Appearance: What Is Acceptable?.