The Cleaning Validation Workshop 2018 covers topics such as:
- 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
The Cleaning Validation Workshop 2018 brings together attendees with responsibilities in:
- Quality Control
- Quality Assurance
- R&D
- Manufacturing
- Validation