Biotechnology

Wake Tech offers a variety of non-degree, short classes and certificate training programs in the biotechnology field, including hands-on training in biomanufacturing and biopharmaceutical operations in a simulated industrial, current good manufacturing practices (cGMP) environment.


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Aseptic Processing Level ISEF-799642 available classes
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...
CGMP Overview for Medical DevicesSEF-3001KG11 available classes
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...
CGMP Overview for PharmaceuticalsSEF-3001KH12 available classes
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...
Cleanroom Gowning CertificationSEF-792441 available classes
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...
Elements of Good Documentation Practices (GDP) and Data IntegritySEF-3001KJ11 available classes
An overview of Good Documentation Practices, including the differences between documents and records, the typical ISO 9001 document hierarchy, and each document level. Participants will become familiar with record-keeping requirements including the electronic signature and o...
Fundamentals of ValidationSEF-165CL1 available classes
This course is designed to introduce technicians and professionals to the principles and regulatory requirements of current drug, biologic and medical product validation.
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...
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...
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...
Biowork: Process Technician TrainingBTC-3200A7
This course is designed to provide basic preparation for entry-level process technician jobs in bioprocess manufacturing, pharmaceutical manufacturing, and chemical manufacturing. Course competencies include understanding the role of a process technician, safety, quality pro...
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