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
FDB3523
