James P. Stumpff

home / authors / james-p-stumpff

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

Articles

Remote Inspections - Lessons Learned

Remote Inspections - Lessons Learned

James P. Stumpff;Siegfried Schmitt
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.

littlewolf1989/Stock.Adobe.com

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

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
Published: October 28th 2024 | Updated: November 21st 2024
Discovery to Commercialization: The Right Partnerships are Key to Streamlined Drug Development
Published: November 15th 2024 | Updated: November 21st 2024
Solving Challenges with AAV Aggregate Analysis Using a Novel Size Exclusion Particle to Determine CQAs
Published: October 28th 2024 | Updated: November 21st 2024
Cell-based phenotypic screening with Incucyte® Live-Cell Analysis Systems
Optimizing cGMP Facility Design Space with a Hybrid Approach
Published: October 22nd 2024 | Updated: November 21st 2024
Optimizing cGMP Facility Design Space with a Hybrid Approach
© 2024 MJH Life Sciences

All rights reserved.