Julie Lippke

home / authors / julie-lippke

Julie Lippke, analytical research and development at Pfizer Inc., Groton, CT

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
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 10th 2024 | Updated: September 18th 2024
CPHI Milan Announces 2024 CPHI Pharma Award Finalists
Published: August 21st 2024 | Updated: December 26th 2024
Pharmaceutical Technology Editorial Advisory Board
Leveraging Integrated Patient-Centric Innovations When Developing Today’s Biologics
Published: November 25th 2024 | Updated: December 26th 2024
Leveraging Integrated Patient-Centric Innovations When Developing Today’s Biologics
Drug Digest: Challenges and Triumphs in Next-Generation Biotherapeutic Development
Published: December 20th 2024 | Updated: December 26th 2024
Drug Digest: Challenges and Triumphs in Next-Generation Biotherapeutic Development
Europa Perspectives: Helping to Navigate the Regulatory System
Published: February 23rd 2024 | Updated: December 26th 2024
Europa Perspectives: Helping to Navigate the Regulatory System