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:
- Learn FDA requirements, critical elements and good documentation practice
- Implement a risk-based approach enterprise-wide
- Understand where, when and how to conduct risk assessments
- Develop a life cycle approach from process design to verification
- Learn how to detect residuals and contaminants
- Define risk-based critical cleaning process parameters and critical quality attributes
- Understand the importance of coupon studies
- Master the visual inspection
- Set acceptance criteria and health-based limits
- Determine the level and frequency of testing needed for routine monitoring
- CIP – Understand use of laboratory scale models to develop robust cleaning recipes
- Learn how to handle failure investigations
- Receive example documents – templates, checklists, worksheets and a Validation Master Plan
- Implement a personnel training program and gowning procedure
- 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
Pricing & Registration
Click Here to return to Cleaning University and register for the Cleaning University Passport which gives you access to all three (3) tracks: Cleanroom Operations, Cleaning Validation, and Environmental Monitoring
For An Additional $995, You Can Earn 1.5 Graduate Credit Hours Towards Temple’s RAQA Graduate Program! For More Information, Email INFO@KENX.ORG, Call 856-281-7134 or Register Above.