Cleaning Validation Workshop 2018

Topics

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

Who should Attend

Attendees with responsibilities in:

• Quality Control
• Quality Assurance
• R&D
• Manufacturing
• Validation