Risk-Based Cleaning Validation

As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation program. With the FDA’s risk-based regulatory initiatives focusing new attention on the risks of cross-contamination understanding lifecycle management techniques for an effective cleaning validation program is paramount. This training course covers the risk-based approach to cleaning validation.

Areas Covered in the Session :

• Regulatory Requirements for Cleaning Validation
• Elements of a cleaning validation program
• Risk Assessment and Risk-based Validation:
  • Benefits
  • Identification
  • Controls and monitoring
  • Establishing appropriate limits
  • Analysis
  • Evaluation
  • Reduction
• Understanding process control and capability
• Effective self-audit of a cleaning validation program

Who Should Attend:

• Quality Departments
• Engineering Departments
• Production Departments
• Manufacturing Departments
• Validation Departments
• Operations Departments
• Process Owners
• Quality Auditors