Thomas Cullen

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Thomas Cullen, analytical research and development, AbbVie Inc., North Chicago, IL

Articles

Risk-based ATR

A Harmonized Approach to Performing a Risk-Based Audit Trail Review

Julie Lippke;Joseph Mongillo;Thomas Cullen;Christian Metz;Katria Harasewych;Fouad Benamira
September 2nd 2022

The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.

Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing

Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing

Thomas Cullen;Cliff Mitchell;Julie Lippke;Joseph Mongillo;Koottala S. Ramaswamy;Thomas Purdue
August 2nd 2021

Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.

GORODENKOFF - STOCK.ADOBE.COM

Assessing Data Integrity Risks in an R&D Environment

Julie Lippke;Joseph Mongillo;Thomas Cullen;Chase Waller;Katria Harasewych;Zahid Muhammad;John Bennett
August 2nd 2020

A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.

Latest Updated Articles

Buy, Sell, Hold: Cell and Gene Therapy
Published: October 11th 2024 | Updated: October 18th 2024
Buy, Sell, Hold: Cell and Gene Therapy - Part 1
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Published: September 10th 2024 | Updated: September 18th 2024
CPHI Milan Announces 2024 CPHI Pharma Award Finalists
Published: October 28th 2024 | Updated: November 22nd 2024
Discovery to Commercialization: The Right Partnerships are Key to Streamlined Drug Development
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Published: November 6th 2024 | Updated: November 22nd 2024
Automate Aseptic Filling: Closing the System at Full Modularity
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Published: November 5th 2024 | Updated: November 22nd 2024
Untethered Data: Unifying and Contextualizing Drug Discovery Data
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Published: November 8th 2024 | Updated: November 22nd 2024
Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification