Andrew Walsh

 Andrew  Walsh

Andrew Walsh is founder and president of Clean6Sigma, LLC a consulting firm specializing in cleaning validation and providing training on cleaning and statistics and risk assessments for cleaning processes.

Walsh has more than 17 years of qualification and validation experience in pharmaceutical and biotech companies. Prior to entering the pharmaceutical industry, Walsh worked for 10 years at the Colgate-Palmolive Co. and the Clorox Co., as an analytical chemist and microbiologist. He joined the Johnson & Johnson (J&J) Pharmaceutical Research Institute in 1990 for the startup of a Protein Development Center where he performed Equipment Qualification and System Validation of Utilities. Andrew Walsh moved to J&J’s Ortho-McNeil Raritan facility where he developed the Cleaning Validation program for the facility. Andrew Walsh wrote Cleaning Policies SOPs, Masterplans and developed swab methods using HPLC and Total Organic Carbon analysis. Walsh moved to J&J Ortho-Biotech to support a Process Validation for the process change and scale up of the company’s Erythropoeitin (EPO) product in Manati, Puerto Rico. He joined Schering Plough as Manager of Cleaning Validation for their Kenilworth facility. Walsh then joined Hoffmann-La Roche where he led several multi-functional teams involved in Computer Systems Validation and Equipment Qualification. Andrew Walsh was also involved with several Six Sigma projects at Hoffmann-La Roche.

Walsh is currently chairing a committee to write a new science and risk based Cleaning Guideline for the International Society of Pharmaceutical Engineers (ISPE) and the American Society for Testing and Materials (ASTM). Andrew Walsh is also a member of ISPE's new Risk-MAPP (Risk-Based Manufacture of Pharmaceutical Products) Guideline team. Andrew Walsh is a well known industry speaker on Cleaning Validation and has given numerous presentations over the past 10 years with the International Institute for Research, Barnett, Centers for Professional Advancement, WorldPharm, Institute for Validation Technology and ISPE.

Andrew Walsh holds a B.S. degree in Biology from Fairleigh Dickinson University, and a M.S. degree in Biology (spec. in Microbiology) from Fairleigh Dickinson University.


Faculty Member Courses Taught:

Course #Course/Program NameRole
PME640Contemporary Concepts in Pharmaceutical ValidationInstructor
PME/ME555Lean Six Sigma In The Pharmaceutical IndustryInstructor
PME/ME/CHE541Validation of Computerized SystemsInstructor
PME/ME/CHE540Validation and Regulatory Affairs in Pharmaceutical ManufacturingInstructor
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