Andrew Walsh, US

Andrew Walsh, US

Andrew Walsh is president of the Center for Pharmaceutical Cleaning Innovation (CPCI™), a not-for-profit research and educational organisation and laboratory whose purpose is to support pharmaceutical, biologics, cosmetic, and medical device companies in the implementation of the science, risk, and statistics-based approaches of the ASTM E3106 “Standard Guide on Science-Based and Risk-Based Cleaning Process Development and Validation”. CPCI supports companies through its research into developing new technologies (two patents), its educational offerings (courses, workshops, and publications), and internship opportunities for students.

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 then worked in the field of validation for over 30 years for major pharmaceutical companies; Johnson & Johnson (RWJ Pharmaceutical Research Institute, Ortho-McNeil, and Ortho-Biotech), Schering-Plough, and Hoffmann-La Roche.

After leaving Hoffmann-La Roche in 2007, Andy founded Clean6Sigma, LLC, to provide consulting services in cleaning process development, and cleaning validation to pharmaceutical, biotech, and medical device companies using lean and six sigma techniques.

In 2008, Andrew became a full-time professor at Stevens Institute of Technology in their pharmaceutical manufacturing and engineering program, where he developed and taught validation and lean six sigma in pharmaceutical manufacturing courses until 2015. In 2019, Andrew joined the Temple University school of pharmacy regulatory affairs and quality assurance program to teach a graduate level course in cleaning validation. Andrew recently published a textbook, “Cleaning Validation: Science, Risk and Statistics-based Approaches”, for use in his classes.

Andrew is very active in developing industry consensus standards with the American Society for Standard and Materials (ASTM International) and has led the teams writing the E3106 “Standard Guide on Science-Based and Risk-Based Cleaning Process Development and Validation”, the E3219 “Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)”, the G121 “Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents”, the G122 “Standard Test Method for Evaluating the Effectiveness of Cleaning Agents and Processes”, and the E3263 “Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues”. Andrew was also a co-author of the ISPE “Risk-based Manufacture of Pharmaceutical Products Guide” (Risk-MaPP) and is on the team updating the PDA Technical Report No. 29 on cleaning validation.

Andrew has an master’s in biology (microbiology) and is a certified lean six sigma black belt and an accredited trainer.

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