ARTICLES BY JERRY CHAPMAN

• How Do FDA, MHRA, & Russia’s Drug Inspectorate Evaluate & Escalate Inspection Findings?

  Representatives from the Russian Federation State Institute of Drugs and Good Practices, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. FDA share their processes for evaluating and escalating inspection findings to determine if regulatory action is needed.

• Comparing The Top 10 Pharma Inspection Findings From FDA, MHRA, & Russia’s Drug Inspectorate

  Representatives from the Russian Federation Ministry of Health, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. FDA share their top 10 pharma company inspection findings from FY2019, revealing many similarities and a few differences.

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

  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

  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.

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

  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

  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

  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

  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.

• Cybersecurity Among Biggest Challenges For Pharma Firms Incorporating Digital Health Technologies

  This is the second of two articles, this part focuses on the importance of cybersecurity and software maintenance, how time scales and methods of execution differ from those in traditional pharma, how agile software development works, and how to avoid potential pitfalls.

• Pharma Quality Systems Need Revamping To Accommodate Digital Health Tech

  As biopharmaceutical companies develop and market more medical devices and combination products with digital health components, the FDA and industry experts caution about regulatory and business risks.

• How Amgen Uses AI Tools To Improve Manufacturing Deviation Investigations

  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

  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

  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. 

• MHRA Ramps Up Data Integrity, Global Supply Chain Security Efforts

  Learn what U.K. MHRA Senior GMDP Inspector Tracy Moore had to say about MHRA’s efforts in the areas of drug/device supply chain security and international efforts on harmonization of data integrity.

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

  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.