Wake Tech offers a variety of short, non-degree classes and certificate training programs in biotechnology. They provide hands-on training in biomanufacturing and biopharmaceutical operations in a simulated industrial, current good manufacturing practices (cGMP) environment.
Interested in earning a degree to work in the biotech industry? Visit Wake Tech's Biotechnology Department.
Workforce Continuing Education offers financial assistance for many workforce training programs through the Propel program and other resources. Email [email protected] for more information.
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, solution preparation, sterile filtration, sterilization methods and cleanroom behavior. Topics are correlated to regulatory guidelines.
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The BioWork Process Technician course is designed to provide basic preparation for entry-level process technician jobs in bioprocess manufacturing, pharmaceutical manufacturing, and chemical manufacturing. BioWork provides competencies to include understanding the role of a process technician, safety, quality processes, measuring process variables, transforming matter, process technology (including processing equipment and plant utilities), controlling the process, maintaining sterile processes, and growing living cells. BioWork graduates are sought after to become employed in the Biopharmaceutical Industry here in Wake County and the surrounding counties. BioWork certification feeds in to two separate Wake-Tech degree programs, which means a BioWork graduate can pursue their associates degree here at Wake Tech after being hired in the industry. Many industries in our area provide educational benefit for their employees. What that means for the BioWork graduate is a job, and the potential to earn a degree with very little out of pocket costs, which equals not only employment opportunities but also opportunities for advancement. BioWork is also a Propel Scholarship sponsored program here at Wake Tech, which means you can potentially earn this certification for free. If you think this is for you, all you have to do is apply and register today.
| Section | Start Date | End Date | Location | Instructor | Price | Open Seats | |
|---|---|---|---|---|---|---|---|
| 301658 | RTP Campus | 180.00 | 8 | Register | |||
| 301659 | RTP Campus | 180.00 | 13 | Register | |||
| 301778 | Western Wake Campus | 180.00 | 18 | Register | |||
| 301779 | Western Wake Campus | 180.00 | 14 | Register | |||
| 301781 | Southern Wake Campus | 180.00 | 9 | Register | |||
| 301780 | Southern Wake Campus | 180.00 | 9 | Register |
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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 hands-on learning.
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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) as well as the relevant ICH and FDA guidance documents.
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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 assessment tools used in audits – as well as how to plan, conduct, and report audits. The course is appropriate for those new to auditing, experienced auditors taking on lead auditor responsibilities, and senior management responsible for resourcing audit efforts and assessing the information obtained.
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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. Labs provide hands-on experience with shaker and bioreactor production, media preparation, and use of analytical lab equipment.
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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, function and behavior of the 4 groups of biomolecules (carbohydrates, lipids, nucleic acids, and proteins) with special emphasis on applications to biomanufacturing and related industrial activities.
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The application of fundamental microbiological concepts and identification techniques are critical for a wide range of manufacturing processes regulated by the FDA, USDA, and other agencies. These include producers of pharmaceutical, food, beverage, and dietary supplement products. This course covers the basic theories and techniques of bacteria and fungi detection, isolation, enumeration, and identification of microorganisms commonly found in industrial settings. Also included are regulatory requirements, methods and rationale for environmental monitoring assessments, reporting, and microbiological quality control. Materials will be covered through a combination of informational lectures and hands-on laboratory exercises.
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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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Lectures will present an overview of Good Laboratory Practice Standards (as defined by the EPA, 40 CFR Part 160 of the Federal Register, and the FDA, 21 CFR Part 58 of the Federal Register) for conducting acceptable regulatory laboratory studies in support of both pesticide and drug registrations. The course includes exercises in the evaluation of protocols, using SOPs for the preparation of standard solutions and the rejection of data, and the evaluation of laboratory labels. Students will gain a broad understanding of the requirements reinforced by class exercises for conducting acceptable FDA and EPA studies.
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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 provide detailed information on the chemical composition of a sample. HPLC is commonly used in quality control or research laboratories in the biotechnology, chemical, agricultural, pharmaceutical, dietary supplement, and cosmetic industries. This course will focus on the basic applications of HPLC, including an introduction to separation science, detection methods, and the varieties of chromatography modes via HPLC. Additional topics include instrument orientation and operation, maintenance and troubleshooting, method development, sample preparation, and data analysis. Laboratory sessions will include hands-on experience in operation of an HPLC system.
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This course will focus on the details of the typical processing procedures utilized to produce a biopharmaceutical - a pharmaceutical produced by biotechnology. An understanding of the science and the equipment commonly used in each process step will be presented along with a review of the basic biochemistry involved in biotechnology and current pharmaceutical applications. Hands-on laboratory exercises will provide experience in the fermentation, product isolation, and purification of a protein.
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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. Students will perform standard preparation, reagent preparation, and sample extractions for HPLC analysis. Participants also learn to follow a method developed to determine trace levels of an organic contaminant in biological samples.
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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 thorough understanding of sterilization, sterile equipment design, the regulatory requirements associated with sterilization and the methods used to test and validate sterile processes. In addition, this course provides participants with an in depth understanding of controlled temperature environments, as well as, the current methods used to validate them in the biotech/pharmaceutical industry. Equipment covered includes validation of incubators, cold rooms, warehouses and freezers.
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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 barrier isolators, and release testing of a final product. Topics of classroom instruction include FDA regulations pertaining to process simulations, review of microbiology including endotoxins, biosafety levels and water system review.
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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) submissions, and FDA inspection strategies for industry validation programs. Other topics include risk-based approaches to developing a validation program, maintaining a validated state, and generating proper validation documentation.
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Biopharmaceutical fermentation involves propagating mammalian, yeast, or microbial cells to produce the desired drug product. This process can be used to produce many types of products, including antibiotics, hormones, amino acids or therapeutic proteins. In this course, students will be able to learn the fundamentals of fermentation technology and processes utilized in the chemical and biotechnology industries. The lab sections will allow the students hands-on experience with a small-scale fermentation process equipment used in the biopharmaceutical industry. Students will also be introduced to the various conditions necessary for sterile media preparation and culture operations.
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Learn the process for validation of automated equipment and process control systems typically found in the biomanufacturing or pharmaceutical facilities using GAMP 5 and other guidelines. Highly interactive activities including discussion of case studies and hands-on development of documentation are provided.
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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 the upstream and downstream processes of the manufacturing of a pharmaceutical product. The Capstone Center is a fully functional facility containing state-of-the-art equipment, analytical technology and a clean room production environment (certified cleanroom suite) that provides a realistic experience for participants.
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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 complete three consecutive gowning trials to earn the certification. Successful gowning attempts are determined by the results of environmental monitoring, ensuring that the gown remains sterile.
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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 security, data integrity, backup and recovery. Hands-on exercises allow students to use validation principles through assessments to determine the level of validation required, writing validation plans, protocols, executing protocols, and analyzing results. Case studies and simulated validation deviations allow participants to experience real-life situations while honing problem-solving skills.
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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 the potential for illness or death of patients and consumers. This course provides the foundational knowledge of aseptic practices required for processing sterile products and maintaining customer safety. In this course, students will be introduced to the regulatory requirements for sterile product manufacturing, the consequences of microbial contamination, and the best practices and behaviors in a cleanroom. Students will be introduced aseptic processing topics such as environmental monitoring, endotoxin testing, cleaning and disinfection, cleanroom design and controls, sterilization processes, aseptic gowning, formulation, and sterile filtration.
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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 other regulations in 21 CFR Part 11. Additionally, the appropriateness and qualification of Excel spreadsheets for record-keeping will be reviewed along with how general good practices incorporate FDA compliance requirements outlined in the Guidance to Industry document Data Integrity and Compliance with CGMP.
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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 and thoroughness, and an understanding of real-time preparedness can help to reduce employee stress during an actual audit. This course equips professionals who will experience FDA audits to maintain compliance by following and documenting in accordance with CGMP.
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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 course equips professionals whose responsibilities depend on operating in CGMP and regulated facilities.
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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 consequences of non-compliance. An introduction to ISO certification and the similarities to Quality Systems Regulations (QSR) will be discussed. The importance of Good Documentation Practices (GDP) with respect to CGMP compliance will be stressed.
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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, implementing air showers for exit procedures, the use of isolators, and facility design considerations.
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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 discussions will be utilized. Additional topics include microbiology, environmental monitoring, personnel monitoring related to aseptic gowning, and key elements of developing an aseptic gowning qualification program.
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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 that make them effective, and the importance of keeping these current. Students will learn how to structure an SOP and the content that should be included. Hands-on activities include reviewing and critiquing an SOP for completeness and effectiveness, as well as practice writing SOPs.
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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, record-keeping requirements (including for 21 CFR Part 11), and the appropriateness of Excel spreadsheets for record keeping. The course also reviews general good documentation practices, incorporating the requirements of the FDA's Guide to Industry Data Integrity and Compliance with CGMP.
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Micropipettes are common laboratory devices used to accurately dispense small volumes of liquid samples. This course will focus on the principles of micropipetting used in biotechnology and other laboratory settings. Testing of pipetting skills will be made at the entry of the class and at the end of the course to access the student’s improvement in micropipetting skills. Practical tips and techniques will be discussed and practiced to increase accuracy and precision of pipetting. Ergonomics will be discussed as it relates to the prevention of injuries due to repetitive motions in laboratory situations with particular emphasis on pipetting activities.
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