GUEST COLUMNISTS

• System Impact Assessment: A Risk Management Framework For A COVID World

  Infusing risk management is essential to an organization, especially in terms of facility, utility, and equipment qualification. Although qualification is usually the last step before moving to process characterization and validation, integrating a risk management approach is an effective way to ensure qualification activities are focusing on what matters most — that equipment performs as expected.

• 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.

• Revising Annex 1: A Case Study In Controlling Operating Risks By Understanding Uncertainty

  Unfortunately, the pharmaceutical industry does not understand how to control a risk’s likelihood of occurrence. The current draft of EU GMP Annex 1 is an example of the industry’s focus on a risk’s severity while not understanding or evaluating a risk’s uncertainty and thus defaulting to using the precautionary principle for guidance.

• Advanced Computing In Pharma & Medtech: How Cognitive Biases Can Cost You Millions

  In their race to leverage sophisticated computing technologies (particularly artificial intelligence, robotics, augmented/virtual reality, and IoT), life science companies face a hidden, insidious challenge — avoiding the cognitive biases that can cause them to unwittingly exacerbate already business-threatening cyber risks.

• Good Documentation Practices And Data Integrity: The Conjoined Twins Of Compliance And Good Business Practices

  Establishing a policy of required GDP/DI for all employees from the outset is cheap insurance for the future of your projects. Here's why.

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

  This is Part 1 of a two-part roundtable Q&A focused on human performance in pharmaceutical operations. In this part, we discuss key drivers for human performance improvement, compare lean manufacturing and human performance programs, and provide perspectives on human performance in the context of the rapid scale-up and production of COVID-19 therapeutics and vaccines. 

• Cleaning Process Development: Selection Of Cleaning Agents For Pharmaceutical Products

  This article will discuss how bench-scale studies can be used for selecting the best cleaning agent for certain products and provide answers to the questions "Which cleaning agent provides the best cleaning?" and "Can we demonstrate that two cleaning agents are equivalent?"

• Nephrology Sector Of The Immunology Market: A Major Biopharma Development Opportunity

  Most of the development in immunology to date has happened in rheumatologic, dermatologic, and respiratory indications. Nephrology, on the other hand, the medical branch that focuses on kidney diseases, has few approved treatment options outside of those that are expensive and higher risk, such as dialysis and transplants.