• Moving Beyond Human Error In Biopharma Investigations And CAPA Programs

    Human performance improvement requires special focus and deliberate action by management to move from an old construct of investigating error as a human failure to an new construct where error is a symptom of a problem to be understood, linked to the context in which the error took place, and it is the starting point of the investigation, not its conclusion.

  • Human Performance In Biopharma Operations — Your Problem Isn't Error

    Part 1 of a two-part roundtable discusses key drivers for human performance improvement, lean manufacturing and human performance programs, and perspectives on human performance in the context of the rapid scale-up and production of COVID-19 therapeutics and vaccines. 

  • 5 Operational Priorities For Pharmas In The Wake Of COVID-19

    Consider Gilead’s ramp-up of remdesivir under FDA Emergency Use Authorization, or the efforts of companies racing to bring vaccines and therapeutics for COVID-19 through clinical development, safety and efficacy trials at speeds not seen before. The analogy of changing a tire while driving the vehicle is well known — now picture doing so at 7,000 rpm!

  • Applying The Johari Window To Manage Biopharma Supply Chain Risk

    The recalls of generic versions of the drug valsartan and related products losartan and irbesartan due to nitrosamine impurities have put the spotlight on sourcing strategies and the globalization of the pharma supply chain. The Johari Window model can help minimize the risk inherent in a complex supply chain.

  • Recommendations For Managing Complexity In Biopharma Operations

    There's a tendency in biopharma operations to make things more complex than they need to be. More content in an SOP, additional signatures, new forms, and control loops don't necessarily equate to better.

  • Beyond Human Error: Are Blunt- Or Sharp-End Decisions More Important In The Life Sciences?

    Decisions made upstream in the supply chain can have enormous repercussions downstream at the bedside or in the home, where medications are administered. How do we guarantee that the big and seemingly small decisions being made with each batch manufactured will be the “right” ones when there is so much inherent variability around us?

  • The Top 3 Forms Of Operational Overcomplexity In Pharma Manufacturing — And How To Simplify Them

    We like simplicity. Yet in pharmaceutical operations we have become very good at making things more complex than they need to be.  This article illustrates a few areas where companies tend to make matters worse and highlights areas where both industry and regulatory agency leaders should push back and focus on simplification.

  • Auditor Evaluations: A GMP Auditing Best Practice

    Given the importance of auditor performance, do managers responsible for audit programs solicit and provide feedback on auditors? Very rarely.


James Morris

James Morris has more than 25 years of pharmaceutical management experience in both plant operations and corporate offices, working with Pfizer, Cilag AG, and Mass Biologics in the U.S. and Europe. He has held positions as deputy director QA/QC and regulatory affairs while at Mass Biologics, director of QA/QC for the Biologics business unit of Cilag AG, and several quality assurance and manufacturing roles with Pfizer, culminating as the head of Quality Assurance for Pfizer in Latina, Italy.