Industry Insights

81. How Digital Procedures And eLogbooks Are Transforming Manufacturing 4/17/2026

    Paper-based records still shape many life sciences operations, but they bring hidden risks. Gain inisght into how manual documentation impacts accuracy, efficiency, and compliance.

82. How To Avoid Form 483s For Biopharma Software Validation Failures 8/17/2022

    The FDA will issue a Form 483 for noncompliance in the software validation GxP environment, mostly due to data integrity failures, inadequate written procedures, deficiencies in investigations, and substandard laboratory controls.

83. AI in Pharma: Emerging Use Cases Across The Value Chain 8/20/2023

    What are some of the emerging value cases for artificial intelligence (AI) across processes in four primary functions of the pharmaceuticals lifecycle—Discover, Create, Make and Sell.

84. AstraZeneca's Digitally Connected Strategy For API Manufacturing 12/3/2024

    The company's packing in the latest technology at its APICOM facility in Dublin. A key feature is more effective and timely use of process data.

85. API In Capsule Vs. The Lost Art Of Formulation Development 11/5/2025

    API-in-capsule offers a fast path for early clinical data, but it can't eliminate the need for full formulation development. Weighing the potential for higher total development time and cost is critical.

86. Biopharma Facility Modular Design & Construction: Key Considerations 9/12/2022

    In facility design, the term “modular design block” is used for “pre-engineered” or “predesigned” solutions. This approach suggests that a new facility design need not be unique but can use and leverage a pre-engineered set of component pieces. The further down the supply chain standardized modules and components reach, the wider the benefits.

87. Why Location Matters 1/5/2023

    While many factors can dictate the choice of a CDMO partner, the CDMO's location can have a significant influence on the communications channels, facilities, and skillsets that a potential partner has to offer.

88. Moving Beyond Human Error In Biopharma Investigations And CAPA Programs 11/16/2020

    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.

89. Development And Manufacture Of A Highly Potent OSD Product 10/20/2025

    Highly potent drug compounds require advanced containment and robust technical transfer protocols. CDMOs overcome challenges through meticulous testing, specialized tooling, and strong supplier relationships.

90. The Growing Value of Quality & Compliance Professionals in Decentralized Pharma 5/25/2022

    The phrase “the pharma ecosystem” has begun to pop up. Who is best suited to envision, support, and strategize a quality management vision in our current “ecosystem”? Here are some reasons your company and employees should value the unique skillset of these individuals more than ever.