Katria Harasewych

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Katria Harasewych works in quality at Merck & Co., Inc. (Kenilworth, NJ).

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.

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)
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Published: September 11th 2024 | Updated: September 18th 2024
CPHI Pharma Award Finalists Announced for 2024
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Published: March 27th 2024 | Updated: June 28th 2024
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Published: July 16th 2025 | Updated: July 17th 2025
Mechanistic Hypothesis of Toxicity: Driving Decision Making in Preclinical Translation
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Published: July 4th 2025 | Updated: July 17th 2025
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BIO 2025: Speeding Up Development of Next-Generation Biologics
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