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...
Aseptic Processing Level IISEF-799741 available classes
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...
Biowork: Process Technician TrainingBTC-3200A71 available classes
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...
Computer Application ValidationSEF-798441 available classes
Interactively learn and apply requirements in validating Computer System Applications. By concentrating on information systems and instruction on how to meet requirements of CFR 21, Part 11 Electronic Records, Electronic Signatures, the course includes how to test systems se...
Elements of Current Good Manufacturing Practices in Biomanufacturing ProcessesSEF-795241 available classes
This course focuses on the application of current good manufacturing practices (cGMP) in the production of biopharmaceuticals. An overview of select topics will be covered from current regulations found in sections 210/211 of Title 21 of the Code of Federal Regulations (CFR...
Ethylene Oxide (EtO) Sterilization ValidationSEF-411CL1 available classes
This course provides an overview of the concept of validation with a specific focus on Ethylene Oxide sterilization of medical devices. The course addresses why, what, when, and how to validate from a regulatory perspective, the documentation requirements for 510(k) submissi...
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.
HPLC in Theory and PracticeSEF-796241 available classes
High-performance liquid chromatography (HPLC) is a chemistry technique used to separate compounds of interest from a liquid mixture based on chemical and/or physical properties. When HPLC is coupled with a spectrophotometric detector, it can be used to quantify analytes to p...
Sample Preparation for HPLC AnalysisSEF-178CL1 available classes
Students will execute basic analytical processes and use HPLC (High-Performance Liquid Chromatography) instrumentation to perform analysis of trace organic compounds. You will learn to analyze biological samples for trace levels of drug and pesticide residues using HPLC. Stu...
Sterilization and Controlled Temperature Enironment ValidationSEF-103CL1 available classes
This course provides participants with an in-depth understanding of steam sterilization as well as the current methods of validation for sterile processes in the pharma/biotech manufacturing environment, including Autoclaves and Steam in Place (SIP) Systems, by providing a t...
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