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.

Financial assistance is available for some Biotechnology courses!

You may qualify for a scholarship through the WakeWorks Propel program!

Learn more and apply for a WakeWorks Propel Scholarship

Course Details & Registration Information

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FDA Audit PreparationSEF-3001KI11 available classes
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...
Fundamentals of BiomoleculesSEF-167CL1 available classes
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...
Good Documentation Practices for Medical DevicesSEF-3001KL11 available classes
This course presents the regulatory requirements and best practices for medical device documents, documentation, and record keeping. It covers the differences between documents and records, the ISO 9001 document hierarchy and appropriate content for each document level, reco...
Writing Effective SOPsSEF-3001KN11 available classes
Students will learn how to write an effective Standard Operating Procedure (SOP) as well as why these are a required and essential component of documentation systems in regulated industries. Discussion will include the functional areas in which SOPs are needed, the qualities...
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...
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...
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...
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...
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...
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