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

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Course details and registration information

Validation Documentation
Available Classes
Not currently offered.
Description Course Outline Requirements Intended Audience More Details
Learn the fundamental principles of validation documentation, including different types of documentation, the purpose of each, how they are utilized to ensure compliance, and how to utilize basic engineering documentation in support of qualification. Find out about the tools available to conduct computer, equipment, facility, or utility assessments in order to determine qualification requirements. A general overview of installation, operational and performance qualification protocol content will be provided. Participants will learn to record field measurements in a protocol, record technical observations in the field, and conduct a technical peer review of an executed protocol prior to final approval submission. Interactive in-class exercises will be used to help illustrate concepts and enhance understanding.
Course Objectives
  1. Know the history of validation and the guidance information available today
  2. Be able to identify various types of engineering and validation documents
  3. Understand the content of each document type and its importance to the validation effort
  4. Understand the engineering and validation life cycle approach
  5. Be able to outline best documentation practices
  6. Be familiar with current trends in validation methodology
Outline of Instruction
  1. Definition of terms
  2. History of validation
  3. Overview of current guidance documents
  4. Engineering and validation documents
  5. Assessment tools
  6. Qualification tests and procedures
  7. Documentation practices
  8. New validation trends and developments
Contact Hours
Industry Standard, State, or National Certification
CE to CU Articulation
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
Course Contact Information
Bionetwork Manager
capstonecente[email protected]