Experience (last 15 years):
As an auditor:
Audit of Computer System Validation practices, procedures, activities and deliverables for current systems; Watson; Davie FL 2007
Performed audit of analytical laboratory results, data, metadata and supporting documentation, for released product; Activis, Little Falls, NJ; 2007
Audit of Production Control records process, procedures, and content; Genzyme; Boston; 2011
Data Integrity Audit of API starting material manufacturing and laboratory processes and records; IPCA/Onyx, India; 2014
Audit of CSV program, TrackWise based CAPA system, Laboratory Operations and Controls; Agila/Mylan; India, 2015;
Data integrity audit of laboratory systems, laboratory instrumentation, and associated procedures for use, operation and control. Bayer, Germany, 2017; Allergan, Waco, TX; 2017
As a consultant (not auditor):
Implementation, configuration and validation of TrackWise Process Investigations, Laboratory Investigations and Atypical Events Quality System Element (QSE) workflows; GlaxoSmithKline, Puerto Rico; 2006 - 2007
Implementation and configuration of TrackWise Supplier Change Request QSE workflow for RoHS directive pilot program; GE Healthcare, Wauwatosa WI 2008
Implementation, configuration and validation of TrackWise Change Control, Notice of Event, Laboratory Investigations and CAPA QSE workflows; Review, assess and remediate laboratory instrument qualification process and deliverables; Ben Venue, Cleveland OH 2008 - 2009
Develop Analytical Instrument Qualification (AIQ) Lifecycle Policy, Standards and SOPs, remediate laboratory instrumentation and equipment for alignment to AIQ; Genzyme; Boston 2010-2012
Technical review and compliance assessment during implementation of the following systems: Symphony EtQ CAPA, Investigation, and Change Control Quality System computerized workflows, MES/ERP system, Empower CDAS; J&J McNeil – Fort Washington, PA 2012 – 2014
Assessment, remediation and/or qualification of:
clients’ laboratory operations, validation deliverables, procedures and instrument firmware compatibility for Empower 2 to Empower 3 migration; clients’ Empower custom fields; Waters Empower CSV package deliverables as provided to clients; Waters; Milford, MA 2014 – 2015;
Assess and remediate data integrity issues in validation and operation of PLC/HMI controlled manufacturing equipment; Agila/Mylan; India, 2015
Review and remediate laboratory operations, procedures and practices under Laboratory Quality In Place remediation plan; create qualification deliverables and configuration specifications for laboratory instrumentation with emphasis on minimizing data integrity risk; GlaxoSmithKline; England, 2016
Participant in Laboratory Forensic data assessment team for analysis of extracted chromatography data and audit trails for identification of data integrity issues such as undocumented sample trial injections, aborted injections and sequences, and repeat testing. Perform in-system data integrity assessment within Chromatography and Non-Chromatographic systems through data analysis, audit trail analysis, user role, access control, and functional permission analysis; Wockhardt, India, 2017-2020
Participant in Laboratory Forensic data assessment team for analysis of extracted chromatography data for identification of data integrity issues such as identification of undocumented sample trial injections, system processed/manual integration and reintegration analysis, System Suitability assessment; Kyowa Hakko Bio Co., Ltd, Japan, 2020
Other Experience, not DI related:
Conduct End User training on TrackWise workflows, Query and Dashboard creation; GlaxoSmithKline, Puerto Rico; 2007 and Ben Venue, Cleveland OH 2009
Education:
Ph.D Analytical Chemistry, Virginia Polytechnic Institute and State University (Virginia Tech), 1992
Data Integrity requirements expertise for the following systems:
Lab Applications and CDS: PerkinElmer TotalChrom; Waters Empower, and Thermo Chromeleon;
Lab instrumentation: HPLC, GC, FTIR, UV-Vis, Mass Spectrometer, Particle size analyzers, Near IR, IR, TOC, pH, balances, titrators, and others.
Other quality system software: Electronic document management systems, LIMS systems