Topics covered include:

• A Practical Guide to Applying Impact and Risk Concepts to Equipment Qualification for Non-Critical Processes for Topical and Oral Product Applications
• Design, Qualification, and Validation of Water Systems
• Recent FDA and International Regulatory Efforts Affecting Facility and Utility Systems Design and Qualification
• A Practical Approach to Validation of HPLC Methods Under Current Good Manufacturing Practices
• Equipment Qualification Toolkit
• Basic Operating Principles and validation of Electron Beam Irradiation Systems
• Commissioning issues and Considerations
• Validation of Time Synchronization
• Qualification and Validation of Quality Control Laboratories
• Commentary – The Cubic Case Study: The Qualification/Validation of Equipment Under Changing business Conditions

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 validation processes.