John Y. Lee

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

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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: August 21st 2024 | Updated: December 27th 2024
Pharmaceutical Technology Editorial Advisory Board
Leveraging Integrated Patient-Centric Innovations When Developing Today’s Biologics
Published: November 25th 2024 | Updated: December 27th 2024
Leveraging Integrated Patient-Centric Innovations When Developing Today’s Biologics
Drug Digest: Challenges and Triumphs in Next-Generation Biotherapeutic Development
Published: December 20th 2024 | Updated: December 27th 2024
Drug Digest: Challenges and Triumphs in Next-Generation Biotherapeutic Development
Europa Perspectives: Helping to Navigate the Regulatory System
Published: February 23rd 2024 | Updated: December 27th 2024
Europa Perspectives: Helping to Navigate the Regulatory System