This two-day intensive course presented by invited industry experts covers industry practices, regulatory expectations, and trends in cleaning and cleaning validation. It is designed for biopharmaceutical manufacturers who are concerned about developing or maintaining a high-quality, efficient, and most importantly, compliant cleaning process. The training addresses several current challenges to cleaning and validation in the…
A well-packed chromatography column is critical to chromatographic separations at benchtop- and industrial-scales alike. Low-quality chromatography column packing can cause uneven mobile phase distribution and poor stationary phase contacting, ultimately leading to lower yields, less separation, and reduced product quality. This course is offered in collaboration with Bio-Rad Laboratories, Inc.
Obtain knowledge and hands-on experience with industry-relevant process control instrumentation, hardware, and software, and documentation for control/automation of biomanufacturing operations. Engage in hands-on experiences with process sensors/equipment and their integration with a control system for enacting control strategies. Learn how to connect process equipment and I/O interfaces for use with a commercial control software package.
This intensive hands-on workshop bridges the gap between AI capabilities and regulatory reality in life sciences manufacturing. Participants will gain practical knowledge of how large language models work, learn to design AI systems appropriate for GxP environments, and develop validation strategies that satisfy regulatory expectations. Through a combination of instruction and collaborative design workshops, attendees…
Join STERIS for a one-day educational event designed for professionals in aseptic manufacturing. This program provides the scientific rationale behind current industry best practices as well as regulatory insights and interpretations through a combination of lecture and hands-on training. Learn how to design compliant and defendable disinfectant efficacy studies, strengthen your Contamination Control Strategy with…
Animal models have shaped biomedical testing for decades, but scientific limitations, economic pressure, and ethical concerns are driving a transition toward New Approach Methodologies (NAMs). These human cell-based models offer a more relevant framework for improving translational insight. However, their value depends on assay design and an understanding of the biological question. Human variability should be incorporated into experimental design rather than minimized. The future impact of NAMs depends on developing assays that are biologically relevant, robust, and informative for decision-making.