Workforce Continuing Education Course Catalog
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Biowork: Process Technician TrainingBTC-3200A75 available classes 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... |
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Operations in Biotechnology Processes: An OverviewSEF-79604 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... |
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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... |
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HPLC in Theory and PracticeSEF-79624 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... |
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Micropipetting Techniques for Precision & AccuracySEF-79654 Micropipettes are common laboratory devices used to accurately dispense small volumes of liquid samples. This course focuses on the principles of micropipetting techniques used in biotechnology and other laboratory settings. Discussion will include practical tips and techniq... |
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Analytical Laboratory SkillsSEF-177CL This course provides an introduction to the basic knowledge and skills needed to work in a laboratory. Instruments and equipment utilized in hands-on training include micropipettes and balances. Concepts presented include equipment operation, laboratory documentation, prepar... |
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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... |
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Aseptic Processing Level ISEF-79964 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... |
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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... |
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Basic Concepts of ValidationSEF-79664 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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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... |
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CGMP Overview for Medical DevicesSEF-3001KG1 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... |
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CGMP Overview for PharmaceuticalsSEF-3001KH1 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... |
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Chromatography in Theory and PracticeSEF-79614 Chromatography is a critical operational step in many pharmaceutical downstream processes. In this course, you will learn chromatography fundamentals, design, operations, key mechanisms, and performance testing. Laboratory exercises will provide hands-on experience in both I... |
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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... |
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Cleanroom Gowning CertificationSEF-79244 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... |
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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... |
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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... |
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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... |
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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... |
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Elements of Good Documentation Practices (GDP) and Data IntegritySEF-3001KJ1 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... |
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Elements of Medical Product AuditingSEF-146CL Regulatory authorities are increasingly expecting on-going, competent assessments of internally and externally sourced processes and materials. This course provides foundational information on regulatory requirements and expectations for audits as well as the different types... |
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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... |
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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... |
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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... |
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Fundamentals of MicrobiologySEF-147CL 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 pr... |
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Fundamentals of ValidationSEF-165CL 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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Good Documentation Practices and Data IntegritySEF-211CL This course presents the regulatory requirements and best practices for pharmaceutical documents, documentation, and record-keeping. It includes a review of the differences between documents and records; the typical ISO 9001 document hierarchy, as well as an explanation and... |
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Good Documentation Practices for Medical DevicesSEF-3001KL1 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... |
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Good Laboratory Practices: FDA and EPA RegulationsSEF-79724 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... |
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Introduction to BiomoleculesSEF-79564 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... |
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Introduction to Computer ValidationSEF-79534 This course provides an overview of computer validation and its fundamental principles, for both automation and information systems. The course addresses the CGMP requirements related to computer validation, phases/life cycle of computer validation and computer systems, and... |
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Maintenance Controls for Aseptic OperationsSEF-148CL Learn the roles maintenance personnel perform in aseptic processing facilities. Through lecture and hands-on activities, we'll review proper aseptic techniques, sterility assurance, and cleanroom controls. Additional topics covered include regulatory requirements, cleanroom... |
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Medical Device Current Good Manufacturing PracticesSEF-79944 Learn the principles, requirements, and expectations of Current Good Manufacturing Practices (CGMP) for medical device production. Topics covered include the regulatory definition of what constitutes a medical device, the divisions of the FDA responsible for medical device a... |
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Pharmaceutical Documentation and Record Keeping RequirementsSEF-157CL This course presents the regulatory requirements and best practices for pharmaceutical documents, documentation, and record keeping. Topics covered will include: a review of the differences between documents and records; the typical ISO 9001 document hierarchy as well as an... |
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Project Execution Planning (PEP) for QualificationSEF-79934 A Project Execution Plan (PEP) is much more than a chart showing timescales: It is a document describing how, when and by whom a specific target or set of targets is to be achieved. These targets will include the project’s scope, timescales, costs, quality, and benefits. It... |
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Report Writing; Considerations and Best PracticesSEF-158CL Participants will learn techniques and tools that will help them better organize, write and edit reports and other technical documents. Topics covered will include: developing a document using an outline, choosing a format, identifying the audience, editing skills and clearl... |
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Sample Preparation for HPLC AnalysisSEF-178CL 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... |
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Sterilization and Controlled Temperature Enironment ValidationSEF-103CL 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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Validation DocumentationSEF-79754 Learn the fundamental principles of validation documentation, including different types of documentation, the purpose of each, how they are utilized to ensure compliance, and how to utilize basic engineering documentation in support of qualification. Find out about the tools... |
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Validation of Automated Equipment and Process Control SystemsSEF-79794 Learn the process for validation of automated equipment and process control systems typically found in biomanufacturing or pharmaceutical facilities using GAMP 5 and other guidelines. Highly interactive activities, including discussion of case studies and hands-on developmen... |
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Validation of Upstream and Downstream ProcessingSEF-79854 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 develop... |
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Writing Effective SOPsSEF-3001KN1 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... |
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Upstream Processes: Microbial FermentationSEF-412CL 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, stu... |
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