Cleaning Validation and Critical Cleaning Processes

Develop, Implement and Maintain a Risk-based Program

May 11-12, 2021

*Virtual

An effective Cleaning Validation Program is a critical focus of a regulatory investigation. Having a first-rate program has never been more critical during a time where COVID-19 is changing the way we operate and interact. FDA Warning letters for violations remain high across the globe as industry continues to struggle with compliance and overcome its complicated challenges. This seminar illustrates how to develop, implement and continuously monitor a risk-based program that exceeds regulatory expectations and uses a best-in-class approach to build a successful, safe and compliant program

Top Reasons to Attend:

1. Learn FDA requirements, critical elements and good documentation practice
2. Implement a risk-based approach enterprise-wide
3. Understand where, when and how to conduct risk assessments
4. Develop a life cycle approach from process design to verification
5. Learn how to detect residuals and contaminants
6. Define risk-based critical cleaning process parameters and critical quality attributes
7. Understand the importance of coupon studies
8. Master the visual inspection
9. Set acceptance criteria and health-based limits
10. Determine the level and frequency of testing needed for routine monitoring
11. CIP – Understand use of laboratory scale models to develop robust cleaning recipes
12. Learn how to handle failure investigations
13. Receive example documents – templates, checklists, worksheets and a Validation Master Plan
14. Implement a personnel training program and gowning procedure
15. Maintain stainless steel equipment in sterile environments

Personnel in the Following Environments Should Attend:

• Manufacturing
• Validation
• QA/QC
• Microbiology
• Science and Chemistry
• Cleanroom Management
• Engineering
• Regulatory Affairs
• Compliance
• Laboratory
• Facility Design
• Data Integrity and Data Management