Section I.- Stability Studies in a Global Environment.- Regulatory Perspectives on Product Stability.- Current International Harmonization Efforts.- Update on the WHO Stability Guideline.- Development of a Regional Guideline for the Eastern Mediterranean Region.- The Challenge of Diverse Climates: Adequate Stability Testing Conditions for India.- Requirements for South East Asian Markets.- The Role of USP Monographs in Stability Testing.- Regulatory Requirements for Stability Testing of Generics.- Stability Design for Consumer Healthcare Products.- Challenges of Drug/Devices Pharmaceutical Products.- Practical Challenges of Stability Testing of Nutraceutical Formulations.- Setting Tolerances for Instrument Qualification USP Chapter .- Technical Concepts for Stability Program.- The Concept of Quality-by-Design.- Forced Degradation and Its Relation to Real Time Drug Product Stability.- Low Level Impurities in Drug Substances and Drug Products and the Analytical Challenges in Identification and Quantitation.- Stability of Repackaged Products.- Packaging-Induced Interactions and Degradation.- An Overview of Physical Stability of Pharmaceuticals.- Stability of Split Tablets.- Temperature Monitoring During Shipment and Storage.- Introducing a Science-Based Quality by Design Concept to Analytical Methods Development.- Stability Data and Operational Practices.- Optimizing Stability Data Package to Facilitate NDA/MAA Approval.- Maximize Data for Post Approval Changes.- Use of Statistics to Establish a Stability Trend: Matrixing.- Setting Specifications for Drug Substances.- Setting Specifications for Drug Products.- Highlights of Investigating Out-of-Specifications Test Results.- Strategies for Ensuring Regulatory and cGMP Compliance of Outsourced Stability Programs.- Building and Developing of Relationships with Third Party Laboratories.- Outsourcing Stability Testing: A Tool for Resource and Risk Management.