E16-15: Science, Risk and Statistics in Cleaning Validation

One-Day Course
Monday, November 14, 8:30am – 5:00pm
  Mr. Andrew Walsh, Center for Pharmaceutical Cleaning Innovation, Hillsborough, NJ

Cleaning Validation is a major concern for regulators and can become the focal point of pharmaceutical inspections. Cleaning Validation can involve a significant amount of resources and take a long time to complete. This one-day course will discuss how to introduce science, risk and statistical approaches to cleaning and justify simplification and minimization of the work.

This one-day course will benefit validation specialists, laboratory analysts, QA and QC managers, regulators, and researchers, who are involved in cleaning validation, create masterplans and protocols, develop swab/rinse methods, evaluate cleaning results and write reports.  To get the most out of the course, we recommended that you have at least one year of pharmaceutical experience in Validation, QA or the laboratory analysis of cleaning validation samples.

1. Applying the Concept of Risk to Cleaning
     * Introduction to risk and ICH Q9 
     * Hazard identification in cleaning 
     * Risk assessment in cleaning 
     * Application of risk analysis to masterplanning

2. Cleaning Process Development 
     * Product and equipment cleanability
     * The measurement of cleanability and its applications
     * Design of experiments in cleaning process development
     * “Cleaning Design Space” and its uses

3. Health-Based Acceptance Criteria 
     * Review of historical approaches 
     * Application of ADE/PDE  
     * Risk-based evaluation of cleaning data using process capability
     * Setting cleaning limits based on statistical process Control

4. Risk-Based Selection of Analytical Methods 
     * Risk-based hierarchy of methods 
     * Selective methods vs. non selective methods
     * Total organic carbon analysis
     * Visual inspection

Andrew Walsh is Andrew Walsh is President of the “Center for Pharmaceutical Cleaning Innovation” (CPCI), a not-for-profit organization that provides research, education (on site and online) and consulting services in Cleaning Process Development and Cleaning Validation using Lean Six Sigma techniques. Andrew has over 25 years of Manufacturing, Laboratory and Validation experience with companies including Johnson & Johnson (three companies), Schering-Plough, Hoffmann-La Roche, Colgate-Palmolive and Clorox. Andrew has a B.S. and M.S. in Biology (Microbiology) and is a certified Lean Six Sigma Black Belt and an accredited Lean Six Sigma Trainer.