BioNetwork Training

The BioNetwork Capstone Center provides affordable, high-quality, hands-on training in biotechnology, biomanufacturing, and biopharmaceutical/pharmaceutical operations in a simulated industrial (cGMP) environment.

The Capstone Center is situated in the Golden LEAF Biomanufacturing Training and Education Center (BTEC) at North Carolina State University Centennial Campus. It provides a training environment that mirrors a biomanufacturing plant facility with state-of-the-art classrooms, industrial-grade equipment laboratories, and a certified cleanroom suite.

Industry-recognized credential: BioNetwork Capstone Certificates

Complete in: 12 months or less

For non-credit student support services or to see if you qualify for financial assistance, contact the Career Pathways Program & Student Resources. 

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Course Details & Registration Information

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CGMP Overview for Medical DevicesSEF-3001KG11 available classes
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...
CGMP Overview for PharmaceuticalsSEF-3001KH12 available classes
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...
Cleanroom Gowning CertificationSEF-792441 available classes
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...
Computer Application ValidationSEF-798441 available classes
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-3001KF11 available classes
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 Good Documentation Practices (GDP) and Data IntegritySEF-3001KJ12 available classes
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...
Elements of Supplier and Internal Quality AuditsSEF-219CL1 available classes
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...
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...
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...
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