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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BioNetwork Certificate Programs

BioNetwork Certificate in Pharmaceutical Processing Basics

Certificate Name:

BioNetwork Certificate in Pharmaceutical Processing Basics

Course Description:

The following Pharmaceutical Processing skill sets are fundamental and applicable to all phases of regulated pharmaceutical production. They are recommended as baseline and the necessary foundation to derive the most knowledge and understanding from the other listed BioNetwork Capstone Certificates.  This Certificate’s content is applicable to learners new to the industry or seeking to enter the industry at an entry level technical or professional position.

 

This is our foundational biomanufacturing certificate and is prerequisite for all other certificates in this area. Waivers for prior learning or experience are considered on a case by case basis for courses in this certificate series only.

Requirements:

  • Elements of Current Good Manufacturing (cGMP) Practices
  • Good Documentation Practices and Record Keeping Requirements
  • Deviations, Investigations, and CAPA
  • Fundamentals of Validation
  • Basic Microbiological Laboratory Skills

BioNetwork Certificate in Biomanufacturing

Certificate Name:

BioNetwork Certificate in Biomanufacturing

Course Description:

The biomanufacturing skill sets are important to the understanding of the production of cell-based products. Certificate content is applicable to learners engaged, or interested in positions in process, quality assurance, validation, and/or engineering.

Requirements:

  • BioNetwork Certificate in Pharmaceutical Processing Basics
  • Operations in Biotechnology Processes: An Overview
  • Fundamentals of Biomolecules
  • Fermentation Processes
  • Cell Culture Processes
  • Chromatography in Theory and Practice

BioNetwork Certificate in Aseptic Processing

Certificate Name:

BioNetwork Certificate in Aseptic Processing

Course Description:

The biomanufacturing skill sets are important to the understanding of the techniques and controls necessary to processing sterile products in an aseptic environment.  Certificate content is applicable to learners engaged or interested in aseptic processing, environmental monitoring and quality assurance of aseptic processing activities.

Requirements:

  • BioNetwork Certificate in Pharmaceutical Processing Basics
  • Fundamentals of Biomolecules
  • Aseptic Processing I
  • Aseptic Processing II
  • Fundamentals of Microbiology

BioNetwork Certificate in Analytical Chemistry Laboratory Skills

Certificate Name:

BioNetwork Certificate in Analytical Chemistry Laboratory Skills

Course Description:

The analytical chemistry laboratory skill sets are important to fundamental controls, techniques and instrument applications used in a pharmaceutical analytical chemistry laboratory. Certificate content is applicable for learners engaged or interested in pharmaceutical analysis and the quality assurance of analytical results.

Requirements:

  • BioNetwork Certificate in Pharmaceutical Processing Basics
  • Fundamentals of  Biomolecules
  • Micropipetting Techniques for Precision and Accuracy
  • Basic Analytical Laboratory Skills
  • Analytical Method Validation
  • HPLC in Theory and Practice

BioNetwork Certificate in Microbiological Laboratory Skills

Certificate Name:

BioNetwork Certificate in Microbiological Laboratory Skills

Course Description:

The microbiological laboratory skill sets are important to fundamental controls, techniques and instrument applications used in a pharmaceutical microbiology laboratory. Certificate content is applicable for learners engaged or interested in microbiological assessments and identifications and the quality assurance approval of microbiological results.

Requirements:

  • BioNetwork Certificate in Pharmaceutical Processing Basics
  • Micropipetting Techniques for Precision and Accuracy
  • Basic Microbiological Laboratory Skills
  • Fundamentals of Microbiology
  • Advanced Microbiological Methods

BioNetwork Certificate for Calibration and Maintenance for Controlled Environments

Certificate Name:

BioNetwork Certificate for Calibration and Maintenance for Controlled Environments

Course Description:

The calibration and maintenance skill sets are important to fundamental controls, and maintenance techniques used for pharmaceutical utility system and equipment preventive and return-to-service maintenance activities. Certificate content is applicable for learners engaged or interested in pharmaceutical maintenance and calibration services as well as the quality assurance of those activities.

Requirements:

  • BioNetwork Certificate in Pharmaceutical Processing Basics
  • Operations in Biotechnology Processes: An Overview
  • Maintenance Controls for Aseptic Operations
  • Instrumentation Calibration Program for Life Sciences
  • Fundamentals of Utility Systems

BioNetwork Certificate in Validation

Certificate Name:

BioNetwork Certificate in Validation

Course Description:

These validation skill sets are important to fundamental elements, techniques and regulatory expectation used in pharmaceutical equipment/systems qualification and process validations.  Certificate content is applicable for learners engaged or interested in qualification/validation protocol creation, execution, review, and quality assurance approval.

Requirements:

  • BioNetwork Certificate in Pharmaceutical Processing Basics
  • Validation Documentation
  • Introduction to Computer Validation
  • RiskBased Approaches to Validation
  • Computer Applications Validation


Course Details & Registration Information

Course
HPLC in Theory and Practice
Name
SEF-79624
Available Classes
Not currently offered.
Description Course Outline Requirements Intended Audience More Details
Description
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 composition of a sample. HPLC is commonly used in quality control and research laboratories in the biotechnology, chemical, agricultural, pharmaceutical, dietary supplement, and cosmetic industries. This course will focus on basic applications of HPLC and will include an introduction to separation science, detection methods, and types of HPLC. Additional topics instrument orientation, operation, maintenance, and troubleshooting, method development, sample preparation, and data analysis. Laboratory sessions will provide hands-on experience.
Course Objectives
  1. Be able to describe the importance of HPLC analyses in research and quality control
  2. Understand various applications of HPLC
  3. Develop a broad understanding of the design, operation and control of an HPLC system
  4. Gain hands-on experience in basic HPLC method development, monitoring, maintenance, and troubleshooting
Outline of Instruction
  1. Course introduction, pre-test
  2. Introduction to Chromatography
  3. Lab A - Lab visit, visual overview of HPLC equipment
  4. Introduction to HPLC
  5. Equipment and flow path
  6. Basic Modes of operation
  7. Calibration
  8. Applications of HPLC
  9. Lab B - Preparation of standards for auto-injection and setting up the auto-injector for overnight analysis
  10. Lab C - Generating the calibration curve
  11. Lab D - Preparation of standards for manual injection
  12. Sample analysis and chromatogram interpretation
  13. Statistical Analysis
  14. Lab E - Manual injections and generation of calibration curve
  15. Method development, maintenance, and troubleshooting
  16. Course exam, review, Q&A
Contact Hours
16
CEU's
1.6
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
Participants should have taken at least one post-high school chemistry course that included a laboratory component, have a minimum of two years experience in a biotechnology-related or chemical industry, OR be a graduate of the BioWork program.
Text and Supplies Needed
Clinical Site/Special Facilities
- IBM “MT-M” computer
- Waters “Breeze” HPLC
- Waters “Breeze” 1500 Series HPLC pump
- Waters “Symmetry” reverse phase column
- 20 uL Injection syringe
- Waters 2487 dual wavelength absorbance detector
- Miscellaneous laboratory glassware and pipettes (multiple sizes)
- Solvents and chemical samples
Requirements for Successful Completion of this Course
  1. Attendance 90% or above
  2. Participation
  3. Achieve a minimum score of 70% on the course exam.
Accreditation/Special Approval Requirements
Intended Audience
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment
Related Courses
  • Chromatography in Theory and Practice - SEF-79614
  • Preparation and Purification of Biological Samples for HPLC Analysis - SEF-79824
  • Sample Preparation for HPLC Analysis - SEF-178CL
Course Contact Information
Willie Green-Aldridge
919-515-0232