Christopher H White

Background

About Christopher H White

A dynamic pharmaceutical professional and internationally recognized industry thought leader with over 20 years of experience establishing strategies and programs for computerized systems, quality management, and data integrity. An energetic, innovative, passionate, collaborative, and pragmatic leader who is a problem-solver and accomplished author with a record of creating solutions and strategies to maximize business efficiencies and promotes compliance through implementing high-quality, fit-for-purpose, appropriately risk-based systems and solutions. Industry Leadership: ISPE’s Editorial Review Board Member, Mar 2014 - Present ISPE's GAMP Americas Community of Practice (COP) Steering Committee Member, Nov 2013 - Present ISPE’s Data Integrity Knowledge Series Leader, Founded Dec 2016 – Dec2021 ISPE’s Data Integrity Special Interest Group (SIG) Leader, Oct 2013 – Dec 2021 BioPhorum Information Technology (BPIT) Member, Oct 2016 – Apr 2018 Computer System Validation External Benchmarking Forum Member, Jan 2016 - Dec 2017 Speaker ISPE Boston GAMP Forum on GAMP5 2nd Edition and CSA, Cambridge, MA, Aug 2022 ISPE Annual Meeting Data Integrity Session, San Diego, Oct 2017 IVT Data Integrity Validation Conference, San Diego, CA, Sep 2015 ISPE Annual Meeting Data Integrity Session, Las Vegas, NV, Oct 2014 Publications - Authored GAMP5 Second Edition, Published Jul 2022- Contributor GAMP Good Practice Guide: Enabling Innovation, Published Sep 2021- Authored Data Integrity (DI): Universal Data Integrity System Assessment Template in the Biopharmaceutical Industry. Published Jun 2018- Contributor to Guidance on the User of Agile in a GxP Environment. Published Jun 2017- Authored GAMP Guide: Records and Data Integrity. Published Mar 2017- Authored to GAMP Good Practice Guide: Global Information Systems Control and Compliance, 2nd edition. Published Feb 2017- Authored The Data Quality Equation—A Pragmatic Approach to Data Integrity, Journal Validation Technology, August 17, 2015. Co-author: Gonzalez, L.R- Contributor to Harmonizing USP and GAMP for Analytical Instrument Qualification, Pharmaceutical Engineering, Jan/Feb 2014, Volume 34, Number 1, pp: 46-56. Authors: Vuolo-Schuessler L, Newton M, McDowall R, Smith P, & Burgess, C- Authored the GAMP Good Practice Guide: Risked-Based Approach to GxP Compliant Laboratory Computerized Systems to reflect the new ISPE GAMP5® standard. Oct 2012 - Contributor to USP and the GAMP Guide on Laboratory Computerized Systems – Is Integration Possible? Spectroscopy, Dec 2011