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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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...
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...
Computer Application ValidationSEF-79844
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...
Disinfection, Sterilization, and ContainmentSEF-3001KF1
This course introduces principles of contamination and containment for the biopharmaceutical industry along with responses using various procedures and engineering controls. Additional topics include special gowning requirements and restricted personnel movement, implementin...
Elements of Current Good Manufacturing Practices in Biomanufacturing ProcessesSEF-79524
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...
Elements of Supplier and Internal Quality AuditsSEF-219CL
Regulatory authorities expect ongoing assessments of all processes and materials, and this course will help you understand regulatory requirements and expectations for audits. You will also learn the different types of audits, their purposes, and the investigatory and assess...
Ethylene Oxide (EtO) Sterilization ValidationSEF-411CL
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...
FDA Audit PreparationSEF-3001KI1
This course is designed to help in creating an environment of preparedness and a culture of quality assurance by raising the awareness of FDA compliance in regulated facilities. Maintaining current knowledge of preparation steps, do’s and don’ts, documentation completeness a...
Fermentation ProcessesSEF-79744
Learn the fundamentals of fermentation technology and processes in the chemical and biotechnology industries. Lecture topics include microbial nutrition and growth, sterilization principles, fermentation equipment/instrumentation, operations, and regulatory considerations. L...
Fundamentals of BiomoleculesSEF-167CL
Biomolecules are the end product of bioprocessing, and bioprocessing is an important method used by biopharmaceutical and other life-science industries in the manufacture of marketable products. This course provides students with a basic understanding of the structure, funct...