BioNetwork Training
The BioNetwork Capstone Center provides affordable, high-quality, hands-on training in biotechnology, biomanufacturing, and biopharmaceutical/pharmaceutical operations in a simulated industrial (cGMP) environment.
The Capstone Center is part of the Golden LEAF Biomanufacturing Training and Education Center on North Carolina State University's Centennial Campus. It provides a training environment that mirrors a biomanufacturing plant, with state-of-the-art classrooms, industrial-grade equipment laboratories and a certified cleanroom suite.
Industry-recognized credential: BioNetwork Capstone Certificates
Complete in: 12 months or less
Course details and registration information
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Aseptic Processing ConceptsSEF-3001JV1 Aseptic processing is utilized to prevent contamination and manufacture sterile products to ensure patient safety. Contamination of these drug products via the introduction of microorganisms, endotoxins, or particulates will lead to product failure, product destruction, and... |
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Aseptic Processing Level ISEF-79964 Through lecture and hands-on activities, practice the basics of aseptic operations in a simulated CGMP environment. Topics include microbiology, cleanroom design and control, environmental monitoring, cleaning and disinfection, aseptic gowning, component preparation, solutio... |
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Aseptic Processing Level IISEF-79974 Delve more deeply into the aseptic processing arena with intensive hands-on instruction of aseptic techniques in a simulated cGMP environment. Instruction includes process simulations of closed-system filtrations, hand filling, semi-automated filling, LAF cabinets, BSC's and... |
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Basic Concepts of ValidationSEF-79664 This course is designed to introduce technicians and professionals to the principles and regulatory requirements of current drug, biologic and medical product validation. |
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Biomanufacturing Boot CampSEF-79914 This course allows participants to experience biopharmaceutical manufacturing through lectures and hands-on production of green fluorescent protein (GFP) within a current good manufacturing practices (cGMP) environment. The course details the steps and equipment utilized in... |
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CGMP Overview for Medical DevicesSEF-3001KG1 This course provides an overview of the Food and Drug Administration (FDA) principles, requirements, and expectations for compliance with Current Good Manufacturing Practices (CGMPs) related to medical device manufacture. This will include a review of FDA enforcement and the... |
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CGMP Overview for PharmaceuticalsSEF-3001KH1 An overview of Current Good Manufacturing Practices (CGMP) fundamentals used by pharmaceutical and biomanufacturing companies. CGMP exists to protect the health and safety of patients and consumers which supports the mission of the Food and Drug Administration (FDA). This co... |
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Cleaning and Disinfection for Aseptic Processing AreasSEF-159CL Learn the role and importance of cleaning and disinfection in aseptic processing areas. Topics covered include regulatory requirements, cleanroom environments, basic microbiology, cleaning, disinfection and environmental monitoring. Class is a combination of lecture and hand... |
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Cleanroom Gowning CertificationSEF-79244 In the course's classroom component, students will learn about regulatory requirements and aseptic gowning techniques. Students will then learn aseptic behaviors related to gowning and how to gown in aseptic settings. After this formal training, students must successfully... |
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Cleanroom Gowning ConceptsSEF-3001JW1 Aseptic gowning is a system of donning apparel to prevent the contamination of aseptic processing areas. The Cleanroom Gowning course will establish a framework and requirements for proper sterile gloving and aseptic gowning procedures. E-learning tools and videos, and discu... |
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