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
Fundamentals of Microbiology
Name
SEF-147CL
Available Classes
    Section Location Begin Date End Date Instructor Price Seats Available/Total Seats
181230 BTEC BioNetwork Capstone Learning Center 10/25/2017 10/27/2017 ASHEVILLE-BUNCOMBE TECHNICAL $252.00 9/12
Description Course Outline Requirements Intended Audience More Details
Description
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.
Course Objectives
  1. Be able to define a wide range of fundamental microbiological concepts and theories that are critical to regulated industries of pharmaceutical, food, and dietary supplements.
  2. Be able to explain and demonstrate fundamental techniques of isolation, detection, enumeration, and identification of bacteria and fungi commonly found in industrial settings.
  3. Be able to summarize: features of organisms of interest, environmental monitoring rationale, regulatory requirements, standard methodology, and resources available for interpretation of laboratory results.
  4. Have experience in evaluation of results, reporting and quality control.
  5. Be able to describe rapid methodologies and special interest microbiology topics.
Outline of Instruction
  1. Day 1, Morning Lecture (4 hours)
    1. Introductions, Questionnaires, Pre-course test, Brief Job Description, Goals for Class
    2. Laboratory Safety –BSL 1 and 2 practices
    3. Gold Standard Methods
    4. Introduction to Industrial Microbiology and Bacteria
    5. Colony Morphology, Cell shape, and Gram stain
    6. Quality Control Laboratory Testing
  2. Day 1, Afternoon Laboratory Exercise (4 hours)
    1. Aseptic suite water collection- demo
    2. Aseptic technique practice
  3. Day 2, Morning Lecture (4 hours)
    1. Historical perspective on bacterial identification
    2. Historical understanding of Microbiology
    3. Enumeration (USP 61, FDA BAM)
    4. Preliminary Identification
    5. Medical and Industry Important Fungi
  4. Day 2, Afternoon Laboratory Exercise (4 hours)
    1. Examine previous day tests
    2. Microscopy
    3. Enumeration
    4. Endotoxin- Gel Clot Method (USP 85)
    5. Serology (FDA BAM) demo (hands on time permitting)
    6. Supplemental rapid tests
  5. Day 3, Lecture (1 hour)
    1. Special Topic Microorganisms
    2. Mycoplasma (USP 63)
    3. Viruses (FDA BAM)
    4. Rapid Methods/Confirmatory Microbiology
  6. Day 3, Laboratory Exercise (2 hours)
    1. Examine previous day tests
    2. Complete Laboratory Report
    3. Environmental Monitoring
    4. Group Lab Report presentations and discussion
  7. Day 3, Lecture (1 hour)
    1. Assessment
    2. Review results as a group
    3. Discuss issues presented in assessment
    4. Conclusions and Final Discussion
    5. Open floor for additional questions
    6. Course evaluations
Contact Hours
20
CEU's
2
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
Text and Supplies Needed
Clinical Site/Special Facilities
Requirements for Successful Completion of this Course
  1. Attendance 80% or above
  2. Participation
Accreditation/Special Approval Requirements
Intended Audience
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment
Related Courses
Course Contact Information
Willie Green-Aldridge
919-515-0232