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Republished with permission from Roque A. Redondo     Dissecting the FDA Guideline for Data Integrity - Article #4   Author: Roque A. Redondo VP Automation and Business Development USA Operations – mirus Consulting Group   So far, we are basically half-way on the discussion of the guideline. On this new Article #4, I expect... Read More...

Republished with permission from Roque A. Redondo     Dissecting the FDA Guideline for Data Integrity - Article #3   Author: Roque A. Redondo VP Automation and Business Development USA Operations – mirus Consulting Group   So far, we have discussed the Introduction Section, the Background Section and Question #1. In this article, I will continue with the... Read More...

Republished with permission from Roque A. Redondo     Dissecting the FDA Guideline for Data Integrity - Article #2   Author: Roque A. Redondo VP Automation and Business Development USA Operations – mirus Consulting Group   In this article, I will continue with the discussion of the latest FDA Guideline related to Data... Read More...

Republished with permission from Roque A. Redondo   Dissecting the FDA Guideline for Data Integrity - Article #1   Author: Roque A. Redondo VP Automation and Business Development USA Operations – mirus Consulting Group   In this article, I will try to dissect the latest FDA Guideline related to Data Integrity, titled... Read More...

Photos from GMP University Internal Audits & FDA Inspections Quality Risk Management (QRM) Change Control August 21-23, 2018 | Doubletree Center City | Philadelphia, PA   ... Read More...

  In 2019 KENX brings 11 content-rich knowledge exchange events to both U.S. and European destinations, including, Philadelphia, San Diego, Dubin, Ireland and San Francisco! Click Here to View/Download  ... Read More...