October 9-10, Sheraton La Jolla, CA

Can you implement the best science-based, risk-based, and statistics-based approaches for cleaning validation? Today's regulators are now expecting ADE monographs and risk assessments of your organization's cleaning validation programs. This two-day intensive summit brings together industry leaders to illuminate best practices in cleaning validation.

Featuring In-Depth Coverage On:

• Understanding the 2018 FDA Guidance on Regulatory Submissions for Cleaning Validation
• Current Best Practices for Regulatory Audits of Cleaning and Cleaning Validation Practices
• ASTM Standards in Medical Device Cleaning Validation
• Science and Risk Based Cleaning FMEA and Cleaning Control Strategy
• Process & Cleaning Validation during Technology Transfer of Biologics & Vaccines
• Creating a Robust Cleaning Protocol and Report
• Statistics in Validation - For Non-Statisticians
• Writing Cleaning Validation Master Plans and Ongoing Cleaning Maintenance
• Analytical Approach for Implementation of Visual Inspection
• Establishing Cleaning Validation Limits for Residue
• Strategies for Lean Cleaning Validation Maintenance for Biologics
• Common Issues with Cleaning and Maintaining Stainless Steel Equipment
• Influence of Material Chemistry and Process History on Medical Device Cleaning Analysis and Chemical Risk Assessment
• Optimizing Manual Cleaning Validation Processes and Operator Qualification for Manual Cleaning
• And More!

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