Workforce Continuing Education Course Catalog

Course
Computer Application Validation
Name
SEF-79844
Available Classes
Not currently offered.
Description Course Outline Requirements Intended Audience More Details
Description
Interactively learn and apply requirements in validating Computer System Applications. By concentrating on information systems and instruction on how to meet requirements of CFR 21, Part 11 Electronic Records, Electronic Signatures, the course includes how to test systems security, data integrity, backup and recovery. Hands-on exercises allow students to use validation principles through assessments to determine the level of validation required, writing validation plans, protocols, executing protocols, and analyzing results. Case studies and simulated validation deviations allow participants to experience real-life situations while honing problem-solving skills.
Course Objectives
  1. Understand regulatory requirements related to information systems
  2. Assess the levels of validation needed for computer system applications
  3. Determine key functions within computer systems
  4. Demonstrate proficiency in handling validation deviations
  5. Prepare and respond to requirements of validation auditors
Outline of Instruction
  1. Day 1
  2. - Types of computer application validation
  3. - CGMPS and regulatory requirements
  4. - Industry guidance documents/documentation requirements
  5. - Risk assessments/determining what to test
  6. - Hands-on exercises: case study and team activities
  7. Day 2
  8. - Team assignments
  9. - Creating validation documentation
  10. - Handling discrepancies/deviations during testing
  11. - Lab exercises
  12. - Review
Contact Hours
16
CEU's
1.6
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
Text and Supplies Needed
BioNetwork will provide
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
  • Introduction to Computer Validation - SEF-79534
  • Validation of Automated Equipment and Process Control Systems - SEF-79794
  • Fundamentals of Validation - SEF-165CL
Course Contact Information
Bionetwork Manager