About Clean6Sigma:
Clean6Sigma, LLC was founded in 2007 by Andrew Walsh to provide consulting services in Cleaning Process Development and Cleaning Validation to the Pharmaceutical, Biotech, Medical Device, Nutraceutical, Cosmetic and Food Industries. Clean6Sigma has provided Consulting, Training and Project Management using Lean and Six Sigma techniques to large and small pharmaceutical companies including Actavis, Bristol-Meyers Squibb, Genentech/Roche, C.R. Bard, Johnson & Johnson, Novartis and Takeda Pharmaceuticals among many others.
About Andrew Walsh:
Prior to joining the Pharmaceutical industry Andrew worked for the Colgate-Palmolive and
Clorox companies as an Analytical Chemist and Microbiologist for 10 years where he gained experience with and insight into detergent chemistry, analytical methods (wet and instrumental) including
method development, manufacturing processes and statistical quality control.
Andrew then gained over 25 years of "hands-on" Validation experience working for Pharmaceutical and Biologics companies such as Johnson & Johnson companies; RWJ Pharmaceutical Research Institute, Ortho-McNeil and Orth-Biotech (10 years), Schering-Plough (1 year) and Hoffmann-La Roche (5 years). Andrew's Validation and Qualification experience ranges from Equipment and Utility Qualification to Cleaning Validation to Process Validation and Computer Systems and Spreadsheet Validation.
During this time, Andrew gained experience in all aspects of Cleaning Validation; including writing policies and masterplans, developing cleaning procedures, writing and executing protocols and developing reports, calculating acceptance limits, developing and validating TOC and HPLC methods and developing and qualifying Visual Inspection. Andrew has presented on all of these topics for over 20 years at conferences with organizations such as Barnett, IIR, IPA, IVT, ISPE, Patheon and has also done training workshops with the FDA.
After leaving Hoffmann-La Roche in 2007, Andy founded a consulting company, Clean6Sigma, LLC. In 2014, Andy opened a laboratory in Hillsborough, NJ which is now the site of the "Center for Pharmaceutical Cleaning Innovation" (CPCI) which was officially incorporated and started on January 1st 2016.
Andrew was also an Industry Professor from 2008 - 2015 in the Pharmaceutical Manufacturing and Engineering Graduate Program at Stevens Institute of Technology where he created and taught courses in Pharmaceutical Validation and Lean Six Sigma. While at Stevens, Andrew also founded and directed the Stevens Pharmaceutical Research Center (SPRC) from 2009 - 2015 which focused on Cleaning and Cleaning Validation topics.
From 2004 until present, Andrew has been involved with several industry initiatives concerning Cleaning Validation and was a coauthor of ISPE’s Risk-based Manufacture of Pharmaceutical Products Guideline (Risk-MaPP) and was the Chair of the Team that wrote the proposed ISPE Baseline Guide "Cleaning Process Development and Validation" (ISPE has decided not to publish this Guide for undisclosed reasons). Andrew is currently chairing a team working on an ASTM Standard for Science and Risk-based Cleaning and Cleaning Validation.
Andrew has a B.S. in Biology and an M.S. in Biology (specializing in Microbiology) and is a certified Lean Six Sigma Black Belt (license # GR7764000076AW) and an Accredited Lean Six Sigma Trainer
Andrew then gained over 25 years of "hands-on" Validation experience working for Pharmaceutical and Biologics companies such as Johnson & Johnson companies; RWJ Pharmaceutical Research Institute, Ortho-McNeil and Orth-Biotech (10 years), Schering-Plough (1 year) and Hoffmann-La Roche (5 years). Andrew's Validation and Qualification experience ranges from Equipment and Utility Qualification to Cleaning Validation to Process Validation and Computer Systems and Spreadsheet Validation.
During this time, Andrew gained experience in all aspects of Cleaning Validation; including writing policies and masterplans, developing cleaning procedures, writing and executing protocols and developing reports, calculating acceptance limits, developing and validating TOC and HPLC methods and developing and qualifying Visual Inspection. Andrew has presented on all of these topics for over 20 years at conferences with organizations such as Barnett, IIR, IPA, IVT, ISPE, Patheon and has also done training workshops with the FDA.
After leaving Hoffmann-La Roche in 2007, Andy founded a consulting company, Clean6Sigma, LLC. In 2014, Andy opened a laboratory in Hillsborough, NJ which is now the site of the "Center for Pharmaceutical Cleaning Innovation" (CPCI) which was officially incorporated and started on January 1st 2016.
Andrew was also an Industry Professor from 2008 - 2015 in the Pharmaceutical Manufacturing and Engineering Graduate Program at Stevens Institute of Technology where he created and taught courses in Pharmaceutical Validation and Lean Six Sigma. While at Stevens, Andrew also founded and directed the Stevens Pharmaceutical Research Center (SPRC) from 2009 - 2015 which focused on Cleaning and Cleaning Validation topics.
From 2004 until present, Andrew has been involved with several industry initiatives concerning Cleaning Validation and was a coauthor of ISPE’s Risk-based Manufacture of Pharmaceutical Products Guideline (Risk-MaPP) and was the Chair of the Team that wrote the proposed ISPE Baseline Guide "Cleaning Process Development and Validation" (ISPE has decided not to publish this Guide for undisclosed reasons). Andrew is currently chairing a team working on an ASTM Standard for Science and Risk-based Cleaning and Cleaning Validation.
Andrew has a B.S. in Biology and an M.S. in Biology (specializing in Microbiology) and is a certified Lean Six Sigma Black Belt (license # GR7764000076AW) and an Accredited Lean Six Sigma Trainer
.
Print 