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. 

Get Support

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
Sterilization and Controlled Temperature Enironment Validation
Name
SEF-103CL
Available Classes
Not currently offered.
Description Course Outline Requirements Intended Audience More Details
Description
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 thorough understanding of sterilization, sterile equipment design, the regulatory requirements associated with sterilization and the methods used to test and validate sterile processes. In addition, this course provides participants with an in depth understanding of controlled temperature environments, as well as, the current methods used to validate them in the biotech/pharmaceutical industry. Equipment covered includes validation of incubators, cold rooms, warehouses and freezers.
Course Objectives
  1. The objectives of this course are to provide a thorough understanding of:
    • sterilization
    • sterile equipment design
    • the regulatory requirements associated with sterilization
    • the methods used to test and validate sterile processes
    • controlled temperature environments including design
    • the regulatory requirements associated with them
    • the methods used to test and validate them.
Outline of Instruction
  1. Day One:
    Morning session:
    Introduction to Steam Sterilization
    Autoclave Design
    Regulatory Requirements
    Acceptance Criteria
    Autoclave Testing /Validation
    Troubleshooting

    Afternoon session:
    Field Autoclave Cycle Analysis
    Field Autoclave Validation Techniques for Liquid and Dry Goods Loads
    Use of the Kaye Validator for Autoclave Validation
  2. Day Two:
    Morning session:
    SIP Design
    Regulatory Requirements
    Acceptance Criteria
    Autoclave Testing /Validation
    Troubleshooting

    Afternoon Session:
    Field SIP Cycle Analysis
    Field SIP Validation Techniques
    Use of the Kaye Validator for SIP Validation
  3. Day 3
    Morning session:
    Control Temperature Unit (CTU) Design
    Regulatory Requirements
    Acceptance Criteria
    CTU Testing /Validation
    Troubleshooting

    Afternoon session:
    Field CTU Cycle Analysis
    Field Validation Techniques
    Use of the Kaye Validator for CTU Validation
Contact Hours
24
CEU's
2.4
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
Some validation experience or having taken the Basic Concepts of Validation course is preferred.
Text and Supplies Needed
All materials supplied by the Validation Academy
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