Cleaning Validation 2019

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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