Cleaning Validation Workshop 2018

Trainer

Andrew Walsh

President at Center for Pharmaceutical Cleaning Innovation

Andrew Walsh is a highly experienced Cleaning Validation SME with 38 years of Manufacturing/QA experience and 28 years of "hands-on" Validation experience working for Pharmaceutical and Biologics companies such as Johnson & Johnson (three companies), Schering-Plough and Hoffmann-La Roche. Andrew has developed Cleaning Validation Policies, Master Plans and Cleaning Process Development Reports, developed and validated HPLC and TOC swab methods, wrote and executed Cleaning Protocols and wrote Reports and has lead global teams developing and writing International Standards on Cleaning. 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 has a B.S. and M.S. in Biology (Microbiology) and is a certified Lean Six Sigma Black Belt and an accredited Lean Six Sigma Trainer.

Andrew was a co-author of ISPE’s Risk-based Manufacture of Pharmaceutical Products Guide (Risk-MaPP) and is currently leading a global team Cleaning Validation SMEs that wrote and published the new ASTM E3106-17 "Standard Guide on Science-Based and Risk-Based Cleaning Process Development and Validation" and are working on additional ASTM Standards to support Cleaning Process Development and Validation.

Andrew is President of the Center for Pharmaceutical Cleaning Innovation (CPCI) a not-for-profit research organization, whose purpose is to support the implementation of the science, risk and statistics-based approaches of the ASTM E3106-17 Standard Guide "Science-Based and Risk-Based Cleaning Process Development and Validation". CPCI will be supporting pharmaceutical, biologics, nutraceutical, cosmetic and medical device companies through its research into developing new technologies (2 Patents Pending) and through its educational offerings (publications, courses and workshops) and its educational opportunities for students.

Andrew is also President of Clean6Sigma, LLC a consulting and contract services company guiding companies in the implementation of science, risk and statistics-based approaches to Cleaning Process Development and Validation using their trademarked "Cleaning Validation for the 21st Century®" and "Clean6Sigma®" programs.

Andrew was also an 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

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Speakers

Dr Mithilesh Trivedi

Head - Quality Management, Zydus Takeda Healthcare Private Limited.

Dr Upendra Bahuguna

Head - Quality Management, Zydus Takeda Healthcare Private Limited.

Sanjay Sharma

Head - Quality Management, Zydus Takeda Healthcare Private Limited.