Digitizing your Cleaning Validation Program and Strategy

European Annex 1 encourages companies to develop a “Total Contamination Control Strategy” (TCCS). TCCS starts with proper determination of Maximum Safe Carryover (MSC), calculated based on health-based exposure limits (HBELs), a routine cleaning program to evaluate effectiveness of the steps used, followed by microbial Environmental Monitoring, Water and Utilities Monitoring, HVAC filter qualifications, Media Fills, and personnel monitoring, which completes the contamination control cycle.

• Understand Automation Considerations including Data Integrity
• Be able to properly identify Cleaning Validation Program Risks
• Learn Risk Mitigation Strategies through Digitization
• See a Case Example of Automating MSC/HBELs & Worst-Case Product/API
• Strategies for Harmonizing of CV Master Data Tables
• View Routine Trends and Analysis used in a digitized CV Program
• Learn to Correlate data for assistance with Root Cause Determination using various Trends and Analysis methods
• View common process flow metrics and KPIs

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