Professor Andrew Walsh
|School: Schaefer School of Engineering & Science|
|Department: Mechanical Engineering|
|Program: Pharmaceutical Manufacturing Engineering|
- M.S., Biology, Fairleigh Dickinson University, 1982
- B.S., Biology, Fairleigh Dickinson University, 1976
Stevens Pharmaceutical Research Center (SPRC)
Professor Walsh founded SPRC in the summer of 2009 with 1 full time and 2 part time Research Assistants working on Total Organic Carbon Analysis and Visual Inspection for Cleaning Validation and developing lab practicals for PME courses. Additional areas of research have been added since, including the PAT application of TOC in CIP systems and automation of electronic GMP systems. SPRC has grown quickly to more than 50 ongoing projects, which resulted in 12 posters presented at the 1st Annual SPRC Poster Show on June 15, 2011. 6 of these posters were entered into the NJ-ISPE Student Poster Competition and 1 poster won Best Stevens Graduate Poster. SPRC also presented posters at the Stevens Graduate Research Conference in 2009 (1 poster), 2010 (2 posters) and 2011 (4 posters). SPRC's research efforts are supported by a number of corporate donors including General Electric (Sievers), Waters-ERA, Ecolabs, Texwipe, Alconox, Testos, and Glaxo Smith Kline. In addition, funded research has been provided from AMCOL Health and Beauty Aids, C.R. Bard, and Waters-ERA.
- Over 20 years of Pharmaceutical Industry in Validation at three Johnson & Johnson companies, Schering-Plough and Hoffmann-La Roche.
- Training and Consulting to the Pharmaceutical Industry on application of Lean and Six Sigma principles to Cleaning Process Development and Validation since 2007 (Clean6Sigma, LLC)
Andrew is an Industry Professor in the Pharmaceutical Manufacturing and Engineering Graduate Program and teaches courses in Pharmaceutical Validation and Lean Six Sigma. Andrew is a certified Lean Six Sigma Black Belt and an Accredited Training Associate through the International Association of Six Sigma Certification.
Andrew has over 20 years of "hands-on" Validation experience working in the Pharmaceutical Industry in Equipment and Utility Qualification, Process Validation, Cleaning Validation, Analytical Method Validation, Spreadsheet Validation and Computer Systems Validation. Prior to working in the Pharmaceutical Industy, Andrew had 10 years of prior experience working as an Analytical Chemist and Microbiologist with the Colgate-Palmolive and Clorox companies.
Andrew is also the founder and president of Clean6Sigma, LLC a consulting firm providing training and consulting on the application of Lean and Six Sigma principles to Cleaning Process Development and Cleaning Validation and on using statistics and risk assessment for developing and evaluating cleaning processes. Andy has provided training and consulting to large and small pharmaceutical companies including Actavis, Bristol-Meyers Squibb, Novartis and Johnson and Johnson.
Advisor to the Stevens Pharmaceutical Research Center (SPRC) Graduate Club.
- Team Member and author of ISPE’s Risk-based Manufacture of Pharmaceutical Products Guideline (Risk-MaPP)- published Fall 2010
- Team Leader and principle author of ISPE’s Science and Risk-based Cleaning and Cleaning Validation Guideline - in progress
- Team Leader and principle author of ASTM’s Cleaning Development and Cleaning Validation Standard - in progress
- NJ-ISPE Board of Directors 2008-2011
Provides consulting services to the Pharmaceutical Industry through Clean6Sigma, LLC (www.clean6sigma.com) and through the Stevens Pharmaceutical Research Center in Cleaning Process Development, Cleaning Validation Method Development and Total Organic Carbon Analysis
Honors & Awards
Winner of ISPE Committee of the Year for 2010 - Risk-MaPP (Risk-based Manufacture of Pharmaceutical Products) Task Team Member
International Society of Pharmaceutical Engineers
American Society for Testing and Materials
American Society for Quality
Regulatory Affairs Professionals Society
- Walsh, Andrew. (2011). "Cleaning Validation for the 21st Century: Overview of the New ISPE Cleaning Guide", Pharmaceutical Engineering, November/December 2011. Vol. 31 (No. 6), Download (470 kb PDF).
- Walsh, Andrew. (2011). "Cleaning Validation for the 21st Century: Acceptance Limits for Active Pharmaceutical Ingredients (APIs): Part II", Pharmaceutical Engineering, September/October 2011. Vol. 31 (No. 5), Download (1514 kb PDF).
- Walsh, Andrew. (2011). "Cleaning Validation for the 21st Century: Acceptance Limits for Active Pharmaceutical Ingredients (APIs): Part I", Pharmaceutical Engineering, July/August 2011. Vol. 31 (No. 4), Download (1174 kb PDF).
- Andrew Walsh. (2011). "Microbial Aspects in Cleaning Validation", Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices , Madhu Raju Saghee, Tim Sandle and Edward C. Tidswell, Business Horizons.
- Andrew Walsh. "Leader of “Cleaning for the 21st Century” Program", International Society of Pharmaceutical Engineers Conference Washington D.C. June 2008.
- Andrew Walsh. "Co-Leader of ISPE Risk-MaPP Program", International Society of Pharmaceutical Engineers Conference Washington D.C. June 2007.
PME 530 Introduction to Pharmaceutical Manufacturing
PME 540 Validation and Regulatory Affairs in Pharmaceutical Manufacturing
PME 541 Validation of Computerized Systems
PME 640 Contemporary Concepts in Pharmaceutical Validation
PME 800 Specical Problems in Pharmaceuticals Manufacturing and Engineering
PME 555 Lean Six Sigma in the Pharmaceutical Industry