🎤  HitendraKumar Shah  |  📅  December 7, 2022   |  🕒  10 AM Eastern Time US


Who Should Attend: 

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

Description:

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

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