ARTICLES BY JERRY CHAPMAN

• Life Science Chief Quality Officers Are Redesigning Quality For The 21st Century

  3/27/2019

  With input from FDA and regulators, CQOs are pursuing means to analyze huge data sets, manage complex manufacturing systems, and operate smoothly between varied products, languages, and cultures.

• Reimagining Quality Operations In The Life Sciences

  2/13/2019

  This article examines how to achieve cross-functional ownership of quality and the efforts of the CQO team to build quality for the 21st century, including exploring the creation of formal degree programs in quality.

• Champions Against Nonsense – A Better Way To Talk (And Think) About Quality

  1/30/2019

  This is the second of three articles focusing on an effort to address what appear to be systemic issues across quality departments. This article addresses how to reframe the way we view and discuss quality, how to better engage stakeholders, and an alternate view of how quality can add value to the company.

• Does Quality Even Matter? 10 Things Quality Departments Should Stop Doing Now

  12/13/2018

  Senior quality leaders and the FDA agree quality organizations supporting pharma manufacturing often fall short of providing the support necessary to maintain and increase regulatory compliance and product quality. At the same time, some do not understand their actions and believe they are obstructionist and reflective of a strict compliance mentality with little regard for the business and its success.

• How FDA, Industry, And Academia Are Guiding AI Development In The Life Sciences

  9/28/2018

  Continuously learning systems (CLS) are artificial intelligence (AI) algorithms that constantly and automatically update themselves as they recognize patterns and behaviors from real-world data — enabling companies to become predictive, rather than reactive, with quality assurance.