Science and Risk Based Cleaning Validation

Venue: Hilton Montreal Airport

Location: Montreal, Canada

Event Date/Time: Aug 11, 2008 End Date/Time: Aug 12, 2008
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Compliance Strategies and Emerging Approaches

A Two Day Comprehensive and Interactive Course with Case Studies & Workshop Discussions on:

- The Fundamentals of Cleaning and Cleaning Validation
- New Directions on Cleaning: Industry and FDA
- Cleaning Process Development
- “Cleanability” Assessments and Worst Case models
- Total Organic Carbon Analysis for Cleaning
- Using Risk Assessment in Cleaning Process Development
- Six Sigma and FMEA for Cleaning Programs
- Certifying Visual Inspection as an Acceptance Criteria
- History of Acceptance Criteria and new Statistical approaches to Limits
- Using Total Organic Carbon Analysis for Pharmaceutical Products
- Statistical Evaluation of Cleaning Data Risk
- Cleaning Agent Selection
- Analyses for Cleaning Validation Program
- Using DoE to establish Design Space
- Masterplanning for New Product Introduction in a Multiproduct Facility (Workshop)