ARTICLES BY JERRY CHAPMAN

• FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis

  9/16/2019

  This is the second part of a two-part article counting down the FDA’s top 10 most-common drug GMP inspection citations for the agency’s 2018 fiscal year (FY2018).

• FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018

  9/4/2019

  In this two-part article, FDA supervisory consumer safety officer Dell Moller, Office of Pharmaceutical Quality Operations (OPQO) Division 3 program director Art Czabaniuk, and OPQO Division 3 investigator Lindsey Schwierjohann present the agency’s top 10 drug GMP inspection citations for FY2018 and provide insight into the observations. This part unveils citations #10 through #6, and Part 2 will cover citations #5 through #1.

• 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 Amgen Uses AI Tools To Improve Manufacturing Deviation Investigations

  10/26/2018

  Amgen is piloting a process using artificial intelligence (AI) that has the potential to greatly enhance its ability to trend and find patterns in manufacturing deviations and to prevent their recurrence. The AI tool will look across large data sets and find correlations between obscure signals and events which the previous system could have missed.

• 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. 

• How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often

  7/13/2018

  The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. 

• How AI Tools Will Transform Quality Management In The Life Sciences

  4/16/2018

  FDA officials and leaders in the pharma and medical device spaces agree artificial intelligence (AI) tools could enable a step change in quality management in those industries. Areas that could be impacted include supply chain management, lot release, manufacturing, compliance operations, clinical trial end points, and drug discovery, among others.