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

FDB3523

HitendraKumar Shah

HitendraKumar Shah is a renowned Quality oriented professional with over 20 years of experience in Quality Assurance and Quality Control. During this period, he has been actively involved in process control, Finished product release, Investigations, product recalls and other quality notifications. He has helped numerous companies in ensuring CAPA implementation & effectiveness, Quality system review and reporting, Supplier audit, GMP training, risk assessment and validation activities. His Key Competencies are but not limited to Quality Compliance, Vendor Audit, data integrity, Risk assessment, Qualification & validation, Review and finalization of technical agreements. He is a popular figure on social media for his effective and easily understandable training bites.

membership
  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT


  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance