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
Introduction to Computer Validation
Name
SEF-79534
Available Classes
    Section Location Begin Date End Date Instructor Price Seats Available/Total Seats
182112 BTEC BioNetwork Capstone Learning Center 10/09/2017 10/09/2017 T. Tice $100.00 19/20
Description Course Outline Requirements Intended Audience More Details
Description
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 documentation requirements. Also covered are major areas subject to regulatory inspections and audit by the FDA and other international agencies. Samples of assessment tools are provided.
Course Objectives
  1. Become oriented to regulatory requirements for computer validation
  2. Learn how to determine whether a system requires validation
  3. Discover the major functions that should always be tested during validation
  4. Be able to define and describe the key components and phases of computer validation
  5. Understand what documents should be included as part of validation
Outline of Instruction
  1. Documentation requirements and CGMP
  2. Master plans
  3. Standard Operating Procedures (SOPs)
    a. Contents
    b. Examples
  4. Protocols and documentation requirements
  5. Reports
    a. Contents
    b. Review process
    c. Approval process
Contact Hours
8
CEU's
0.8
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
SEF-165CL, Fundamentals of Validation or equivalent is recommended
Text and Supplies Needed
Clinical Site/Special Facilities
Requirements for Successful Completion of this Course
  1. Attendance 90% 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
  • Fundamentals of Validation - SEF-165CL
Course Contact Information