James P Stumpff

James P. Stumpff, RPh, is principal consultant with Parexel International, jim.stumpff@parexel.com.

Articles

March 15th 2022

This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.

Succeeding With OOS and Root-Cause Investigations

James P Stumpff

July 1st 2020

Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.

Latest Updated Articles

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

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Published: November 6th 2024 | Updated: November 20th 2024

Automate Aseptic Filling: Closing the System at Full Modularity

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Published: November 5th 2024 | Updated: November 20th 2024

Untethered Data: Unifying and Contextualizing Drug Discovery Data

Medium shot of female process supervisor in lab coat pointing at equipment controlling production quality with African American male manufacturing technician, working in protective suit at factory | Image Credit: © Seventyfour - © Seventyfour - stock.adobe.com

Published: November 8th 2024 | Updated: November 20th 2024

Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification

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Published: November 4th 2024 | Updated: November 20th 2024

Strategies for Overcoming Common Challenges in Tech Transfer

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