Workforce Continuing Education Course Catalog

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Aseptic Processing Level ISEF-799641 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-3200A73 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...
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...
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.
Good Documentation Practices and Data IntegritySEF-211CL1 available classes
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...
Good Laboratory Practices: FDA and EPA RegulationsSEF-797241 available classes
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...
Sample Preparation for HPLC AnalysisSEF-178CL1 available classes
Gain hands-on (laboratory-based) experience in sample preparation and purification techniques for use in HPLC (High Performance Liquid Chromatographic) analysis of biological samples for trace levels of drug and pesticide residues. Students will perform standard preparation,...
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...
Basics of BiotechCSP-4000IU21 available classes
Explore biotechnology! This course gives students an introduction into the careers of a biotechnologist. Students will learn through experiences with molecular biology lab techniques, e-textiles, 3D printing, and other experiences in the world of microbes (the smallest livin...
Biomanufacturing Boot CampSEF-799141 available classes
This course will allow NCCCS students to experience industrial biotechnology through lectures and hands-on production of green fluorescent protein (GFP) within a cGMP (current good manufacturing practice) environment. The course will be taught at the Capstone Center, a fully...
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...
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...
HPLC in Theory and PracticeSEF-79624
High performance liquid chromatography (HPLC) is a chemistry technique used to separate chemical compounds of interest from other compounds in a liquid sample. When HPLC is coupled to a detection method, these can be quantified to provide detailed information on the chemical...
Advanced Microbiological MethodsSEF-201CL
The application of advanced microbiological identification techniques is used in a wide range of pharmaceutical, food, and dietary supplement products and manufacturing processes as regulated by the FDA, USDA, and other agencies. This course covers the theories and techniqu...
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...
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.
Basic Microbiological Laboratory SkillsSEF-217CL
This introductory course is for those interested in a career in a microbiology laboratory – or those new to the field who want to build basic skills. These skills are used in the manufacturing processes for a wide range of pharmaceutical, food, and dietary supplement product...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
Preparation and Purification of Biological Samples for HPLC AnalysisSEF-79824
Gain hands-on laboratory experience in sample preparation and purification techniques used in High Performance Liquid Chromatography (HPLC) analysis of biological samples for trace levels of drug and pesticide residues. Participants will prepare chromatography standards and...
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...
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...
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...
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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