Thomas Cullen

home / authors / thomas-cullen

Thomas Cullen works in analytical research and development at AbbVie Inc. (North Chicago, IL).

Articles

Audits and inspections

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

Julie Lippke;Joseph Mongillo;Thomas Cullen;Christian Metz;Katria Harasewych ;Fouad Benamira
November 15th 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 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
July 16th 2021

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

Assessing Data Integrity Risks in an R&D Environment

Assessing Data Integrity Risks in an R&D Environment

Julie Lippke;Joseph Mongillo;Thomas Cullen;Chase Waller;Katria Harasewych ;Zahid Muhammad;John Bennett
October 1st 2020

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

Latest Updated Articles

Exploring New Advancements in ADC Technologies (CPHI Milan 2024)
Published: October 11th 2024 | Updated: March 3rd 2025
Exploring New Advancements in ADC Technologies (CPHI Milan 2024)
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com
Published: September 11th 2024 | Updated: September 18th 2024
CPHI Pharma Award Finalists Announced for 2024
Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com
Published: March 27th 2024 | Updated: June 28th 2024
AbbVie Acquires Landos Biopharma and Gets Full FDA Nod for ADC Product
Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS) | Image Credit: © Tada Images - stock.adobe.com
Published: July 18th 2025 | Updated: July 26th 2025
FDA Grants Regenerative Medicine Advanced Therapy Designation to Gene Therapy for Knee OA
Published: June 30th 2025 | Updated: July 26th 2025
Enhance your CHO cell biomanufacturing processes
Published: June 30th 2025 | Updated: July 26th 2025
An insider look at recent innovations in cell therapy
© 2025 MJH Life Sciences

All rights reserved.