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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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

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Published: June 30th 2025 | Updated: July 26th 2025

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Published: June 30th 2025 | Updated: July 26th 2025

An insider look at recent innovations in cell therapy

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