John Y. Lee

home / authors / john-y-lee

John Y. Lee is Executive Director (Former FDA Investigator) at Pharmaceutical Compliance Associates, US.

Articles

Site Logo

Change management: common failures and a checklist for improvement

Henrik Johanning;John Y. Lee;Christian Hemmingsen
May 1st 2010

Though the pharma industry has improved its change management processes, there are still opportunities for improvement.

Product Annual/Quality Review: US–EU Comparative Analysis and Interpretations

John G. Grazal;John Y. Lee
March 2nd 2008

There are significant differences between the United States and European Union requirements for the annual review of records related to the manufacturing and control for pharmaceutical products and active pharmaceutical ingredients.

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: October 28th 2024 | Updated: November 22nd 2024
Discovery to Commercialization: The Right Partnerships are Key to Streamlined Drug Development
Operator work on infusion pharmaceutical industry | Image Credit: © xmagics - © xmagics - stock.adobe.com
Published: November 6th 2024 | Updated: November 22nd 2024
Automate Aseptic Filling: Closing the System at Full Modularity
Two scientists wearing lab coats and safety glasses analyzing data displayed on a computer screen in a laboratory setting | Image Credit: © NCST Studio - © NCST Studio - stock.adobe.com
Published: November 5th 2024 | Updated: November 22nd 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 22nd 2024
Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification