Certificate

Pharmaceutical Computer Validation

Program code:

Credential:

Certificate

Duration:

Delivery Mode:

Start Date(s):

Computer System Validation (CSV) is a process used to ensure that computer-based systems produce information or data that meet a set of pre-defined requirements. If a computer system meets these specific requirements, it can be assumed that it consistently performs as intended and supports regulatory compliance.Anyone who wants to become a Computer Validation Specialist, Front/Backend Developer, Enterprise Software Professional, Validation Engineer or Specialist, Control/Instrumentation Engineer, Process Engineer or Project Engineer, Quality Assurance Specialist, Quality Control Specialist, Maintenance Engineer, Automation Engineer, Maintenance Technician, or Senior Validation Manager should attend the Computer Validation Training Program.

Learning Outcomes

After successful completion of this course, students will be:
  • Able to understand current computer system validation regulatory requirements
  • Benefits of computer system validation
  • Develop IOQ, PQ protocols as per user requirements
  • Deploy validation plans and reports
  • Able to perform a risk analysis
  • Able to perform re-validation
  • Module 1
    • Computer System Validation
    • Why Do We Need Computer System Validation?
    • CSV Regulatory Requirements
    • Computer System Validation Documentation
  • Module 2
    • CSV Process
    • Mapping Out a User Requirement
    • Writing a Validation Master Plan
  • Module 3
    • Test Cases – Including Installation, Operational, and Performance Qualification (IQ/OQ/PQ)
  • Module 4
    • Validation Protocol
    • Validation Report
    • Case Study: Protocol Writing

Who Should Attend

Anyone who wants to become the following should attend the webinar on pharmaceutical software validation:
  • Computer Validation Specialist
  • Front/Backend Development or Enterprise Software
  • Validation Engineer or Specialist
  • Control/Instrumentation Engineer
  • Process Engineer or Project Engineer
  • Quality Assurance Specialist
  • Quality Control Specialist
  • Maintenance Engineer
  • Automation Engineer
  • Maintenance Technician
  • Senior Validation Manager
  • Validation Assistant
  • Validation Specialists
  • Coordinators
  • Managers