ARTICLES BY JUDY CARMODY

• “The 12 Months Of Quality:” Tips For Building A Voluntary QA Culture In 2019

  Rather than 12 days of gifts, here are 12 months of suggestions to assist you in helping your organization bring its quality efforts and programs to the next level. As you think about where you want to be in 2019, consider these thoughts as strategies for building more credibility, cachet, and value around quality.

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

  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

  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.

• Employing GMP Techniques In GCP For More Robust, Compliant Clinical Studies

  Most of my career has been on the good manufacturing practices (GMP) side of industry, where, despite moments of ambiguity or confusion, everything is presented in black-and-white terms. And over the last five years or so, I have had the pleasure of supporting and/or overseeing the good clinical practice (GCP) side of industry, experiencing the more “human” side of the business.