President, Center for Pharmaceutical Cleaning Innovation
Andrew Walsh is President of the Center for Pharmaceutical Cleaning Innovation (CPCI) a not-for-profit research organization and laboratory whose purpose is to support the implementation of the ASTM E3106 Standard. The CPCI laboratory performs research into cleaning issues and developing new technologies (2 Patents). CPCI provides educational offerings (publications, courses and workshops), consulting and laboratory services and offers internship opportunities for students.
Andrew is an Adjunct Professor in the Temple University School of Pharmacy Regulatory Affairs and Quality Assurance Program and teaches a Graduate level course in “Cleaning Validation” as a part of their Certificate in Validation Science. Prior to Temple University, Andrew was Industry Professor in the Pharmaceutical Manufacturing and Engineering Graduate Program at Stevens Institute of Technology from 2008 to 2015 where he created and taught courses in Pharmaceutical Validation and Lean Six Sigma.
Andrew has over 30 years of “hands-on” validation experience working in companies such as Johnson & Johnson (three companies), Schering-Plough and Hoffmann-La Roche. Prior to joining the Pharmaceutical industry Andrew worked for 10 years at the Colgate-Palmolive and Clorox companies as an Analytical Chemist and Microbiologist.
Andrew was a co-author of the ISPE Risk-based Manufacture of Pharmaceutical Products (Risk-MaPP) Baseline Guide and led the team that wrote the ASTM E3106 Standard and is the Technical Contact for the team that wrote the ASTM E3219 Standard.. Andrew is still leading the same ASTM team and are now are writing several other Standard Practice Guides on Calculation of Cleaning Validation Limits, Qualification of Visual Inspection and Using Total Organic Carbon Analysis and is on the Team that is re-writing the PDA Technical Report #29 “Points to Consider for Cleaning Validation”. Andrew is also working on a textbook for Science, Risk and Statistics-based Cleaning Process Development and Validation for use in his class and then CPCI certified SME Course.
Andrew has a B.S. and M.S. in Biology (Microbiology) and is a certified Lean Six Sigma Black Belt and accredited Trainer.