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

Course
Introduction to Computer Validation
Name
SEF-79534
Available Classes
    Section Location Begin Date End Date Instructor Price Seats Available/Total Seats
188232 BTEC BioNetwork Capstone Learning Center 02/19/2018 02/19/2018 T. Tice $100.00 20/20
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
Willie Green-Aldridge
919-515-0232