The presentation includes discussions on the stages and activities impacting cleaning processes, including:

• Lifecycle Approach to Process Validation
• Lifecycle Approach to Cleaning Validation
• Stage 1. Process Design
• Stage 2. Process Qualification
• Stage 3. Continued Process Verification
• Scientific and technical process
• Demonstrate process works as intended
• Process must remain in control throughout lifecycle
• Cleaning equipment
• Equipment to be cleaned
• Effective documents consistent with the above
• Analytical methods validated (includes sampling)
• Cleaning Validation Problems
• Self-Audit Questions