James Bergum, as President of BergumSTATS, LLC, leverages over four decades of extensive experience in the pharmaceutical industry to provide unparalleled statistical consulting services. His expertise spans a wide array of specialties, including the Design of Experiments (DOE), Process Validation, and Analytical Method Validation, which...
James Bergum, as President of BergumSTATS, LLC, leverages over four decades of extensive experience in the pharmaceutical industry to provide unparalleled statistical consulting services. His expertise spans a wide array of specialties, including the Design of Experiments (DOE), Process Validation, and Analytical Method Validation, which are critical in ensuring the integrity and reliability of scientific research and manufacturing processes. At BergumSTATS, James is dedicated to empowering scientists in both Research and Development and Manufacturing by applying robust statistical methodologies that enhance data analysis and optimize processes.
One of James's key projects involves collaborating with pharmaceutical companies to implement Quality by Design (QbD) principles, which emphasize the importance of understanding variability in processes to ensure product quality. His adeptness in Stability Analysis allows clients to predict product shelf life and performance, ensuring compliance with regulatory standards. By focusing on Good Laboratory Practice (GLP) and Verification and Validation (V&V) protocols, James ensures that his clients not only meet industry regulations but also achieve operational excellence.
James’s ability to communicate complex statistical concepts in an accessible manner sets him apart in the field. He is passionate about mentoring scientists, helping them to grasp essential statistical principles that drive innovation and improve outcomes. His commitment to process improvement and optimization has made BergumSTATS a trusted partner for organizations seeking to enhance their research capabilities and manufacturing efficiencies. With a strong foundation in biostatistics and formulation, James Bergum continues to make significant contributions to the pharmaceutical landscape, positioning his clients for success in an increasingly competitive market.
