ARTICLES BY JERRY CHAPMAN

  • Reimagining Quality Operations In The Life Sciences
    Reimagining Quality Operations In The Life Sciences

    This is the third of three articles focusing on an effort to address what appear to be systemic issues across quality departments, informed by a multinational group comprising chief quality officers (CQOs) from pharma, device, animal health, and consumer goods companies. It will examine 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
    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
    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
    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
    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
    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
    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
    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
    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
    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.

Jerry Chapman

Jerry Chapman

Jerry Chapman is a GMP consultant with nearly 40 years of experience in the pharmaceutical industry. His experience includes numerous positions in development, manufacturing, and quality, at the plant, site, and corporate levels. He designed and implemented a comprehensive “GMP Intelligence” process at Eli Lilly and again as a consultant at a top-five animal health firm. Chapman served as Senior Editor at International Pharmaceutical Quality (IPQ) for six years, producing in-depth reports of interest to industry and regulators in the drug GMP/CMC space.