ARTICLES BY JUDY CARMODY

• The 12 Months Of Quality: Tips For Building A Voluntary QA Culture In A 2021 COVID World

  12/21/2020

  As we say goodbye to 2020, the end of which couldn’t come soon enough, it is fitting to look at how to build a voluntary quality culture in our “new normal” work environment.

• How “Two People With A Molecule” Can Build A Quality Culture

  12/30/2019

  Robert Lutz, Ph.D., is chief science officer of Iksuda Therapeutics, a 20-person start-up developing new antibody drug conjugates (ADCs) to target difficult-to-treat cancers. With an extensive background in ADC development, he believes that building mature quality capabilities is what your company must do every day from day one.

• A Better Approach To Selecting And Overseeing GCP/GLP Vendors And Processes

  10/18/2018

  This is the third article in a series examining strategies that allow quality groups to collaborate with good clinical practice (GCP) and good manufacturing practice (GMP) divisions to improve compliance, increase clinical study robustness, and enhance data integrity.

• 4 Pitfalls To Avoid When Developing GCP SOPs

  8/16/2018

  This article is the second in a series examining strategies that allow quality groups to collaborate with GCP and GMP groups to improve ICH E6(R2) compliance, increase clinical study robustness, and enhance data integrity.