Cleaning Validation Workshop 2018

Key Topics
Current regulatory environment and expectations
Introduction to the new ASTM E3106-17 ‘Standard guide for science based and risk-based cleaning process development and validation
Calculation of cleaning validation limits using Health Based Exposure Limits (HBELs)
Cleaning process developments - Cleanability Studies (determination of Hardest to Clean)
Risk-based selections and justification of analytical methods
Total Organic Carbon (TOC) Analysis
Risk evaluation and risk control strategies