Workforce Continuing Education Course Catalog

Course
Validation of Automated Equipment and Process Control Systems
Name
SEF-79794
Available Classes
    Section Location Begin Date End Date Instructor Price Seats Available/Total Seats
221788 BTEC BioNetwork Capstone Learning Center 03/23/2020 03/24/2020 T. Tice $150.00 20/20
Description Course Outline Requirements Intended Audience More Details
Description
Learn the process for validation of automated equipment and process control systems typically found in biomanufacturing or pharmaceutical facilities using GAMP 5 and other guidelines. Highly interactive activities, including discussion of case studies and hands-on development of documentation, are provided.
Course Objectives
  1. Be able to determine risk assessments and test acceptance criteria based on guidance documents

    perform the following for automated equipment and process control systems:
  2. Be able to outline the validation life cycle, requirements, and system specification documents
  3. Develop test documentation for automated equipment and process control systems validation
  4. Perform testing and accurately report discrepancies/deviations, analysis, and conclusions to meet regulatory audit expectations
Outline of Instruction
  1. Types of automated equipment/process control systems
  2. GMPs and regulatory requirements
  3. Industry guidance documents/ documentation requirements
  4. Risk assessments and determining what to test
  5. Case Studies
  6. Team activity
  7. Creating validation documentation
    Handling discrepancies/deviations during testing
    Lab work
    Re-cap/Discussion
    Assessment/ Instructor Evaluation
  8. Handling discrepancies/deviations during testing
  9. Review and assessment
Contact Hours
16
CEU's
No
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
SEF-165CL, Fundamentals of Validation and/or validation experience 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