Wake Tech offers a variety of non-degree, short classes and certificate training programs in biotechnology, including hands-on training in biomanufacturing and biopharmaceutical operations in a simulated industrial, current good manufacturing practices (cGMP) environment.

For those interested in earning a degree to work in the biotech industry, visit Wake Tech's Biotechnology Department.

Financial assistance available

Workforce Continuing Education offers financial assistance for many workforce training programs through the Propel program and other resources. Email [email protected] for more information.

Course details and registration information

Introduction to Computer Validation
Available Classes
Not currently offered.
Description Course Outline Requirements Intended Audience More Details
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
Industry Standard, State, or National Certification
CE to CU Articulation
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
Bionetwork Manager