Course Catalog - National Center for Therapeutic Manufacturing ...

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14 coursesProcess Control & OptimizationRisk-Based Biotherapeutics Production & DeliveryPresents the concept of Lean Thinking and how lean methodologiesare transforming American manufacturing. Students discuss topicssuch as facilities and workstation layout and design, ergonomics,waste reduction, process flow and queuing network analysis, as wellas “push vs. pull” and “just in time” systems. Emphasis is placed onprinciples and applications of Lean Thinking and the influence ofvariance on optimal systems behavior.Designing for FlexibilityDetails the systematic methods involved in the design of flexiblepharmaceutical manufacturing facilities, such as active pharmaceuticalingredient (API) and formulation and finishing plants. The coursediscusses special considerations for requirements of regulatory environments,building design, critical utility design, and multiproduct facilities.Students learn to develop optimization formulations for nominaland flexible designs, manipulate designs and operation variables toenhance flexibility, synthesize flexible mass-integration and energyintegrationnetworks, and perform team case studies and professionaldesign reports.Bioprocess Dynamics & ControlCurriculum provides an overview of bioprocess modeling and dynamics,bioprocess control, and control systems analysis and design. In additionto developing and implementing dynamic and empirical models usingsimulation techniques, students also learn to analyze and optimizeproperties of dynamic models and bioprocesses. Students participatein team case studies to address bioprocess control-related problems.Pharmaceutical Supply ChainsDiscusses biopharmaceutical industry supply chain concepts and coversthe development stage, raw material producers, equipment producers,manufacturers, distribution channels, and delivery of the medicine tothe patient. Curriculum highlights how regulatory affairs, compliance,risk management, drug properties, quality, and traceability affect thesupply chain and its players.
courses15Human Error & Resilience in Biomanufacturing SystemsExamines how human error impacts the safety and qualityof operations in biomanufacturing processes. Reason’s errorclassification model and the Skill-Rule-Knowledge behavioralmodes model highlight how breakdowns can lead to error. Theinteracting effects of environmental and human factors, such asworkload, stress, and time pressure are also discussed. Systemdesign guidelines and solutions like management strategies,operator practices and training, and other tools that can reducethe likelihood of error commission and also mitigate the negativeconsequences of error are presented.
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Course Catalog - National Center for Therapeutic Manufacturing ...

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