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)