Koshy George

Koshy George

Sr. Cleaning Validation Consultant, Quantic Group, LLC.

Validation and QA Specialist with over 25 years of experience in the pharmaceutical and biopharmaceutical industries. Cleaning Validation SME with hands on experience in developing validation strategies, QA review and approval, evaluate quality management systems, perform audits, quality investigations of GMP activities, recommend CAPA, trouble shooting and cycle development, authoring master plans, protocols and reports, developing procedures to complete validation related gaps, consent decree remediation, GxP and regulatory body requirements, as well as project management.

He has conducted training sessions for cleaning validation specialists. He has helped to find root cause to several persistent cleaning validation failures. He has worked with cleaning validation teams under Consent Decree in Wyeth, Schering-Plough, J & J-McNeill, and Sanofi-Genzyme. He has been an instructor of Cleaning Validation with IVT, IPA and PDA. He has served in the team that developed the PDA Technical Report #29 (Revised in 2012) “Points to Consider for Cleaning Validation”.

Upcoming Events

Regulatory Requirements and Principles for Cleaning Validation: 2-Day In-person Seminar
- Tampa, FL | Thursday, December 6, 2018 | Friday, December 7, 2018
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