Topics covered include:

• Risk-based Approach for Biological Process Validation: Integrating Process Validation With Product Development
• A Practical Application to Cold-Chain Shipping and Associated Validation Activities: Part 2 of 2
• Process Validation Toolbox
• The Role of Control Charts in Process Validation
• Validation of Sterilizing Filters for a Specific Process
•  Process validation Acceptance Criteria for Bulk Mixes and Bulk Products
• Planes, Trains and Automobiles: Simulated Distribution of FDA-Regulated Products for Packaging Validation
• Ask the FDA: Critical Factors Which Effect Conducting Effective Process Validation: One FDA Investigator's View
• Six Sigma and Process Validation Strategies - Part I
•  Six Sigma and Process Validation Strategies - Part II
• Process Validation Issues: A Discussion with Robert C. Coleman, USFDA
• Practical Validation Issues

These articles were provided to IVT by leading validation professionals, and are now compiled as a single, easy-to-use resource to assist you in your process validation processes.