Three-Day Virtual Computer Systems (CSV) Validation Training Course: Principles, Methods and Best Practices – December 13-15, 2021

Dublin, 01 Dec. 2021 (GLOBE NEWSWIRE) – Less than two weeks to register for the “Computer system validation training (CSV)” training course has been added to offer.

This course is designed to fully immerse you in the principles, methods and best practices of Computer System Validation (CSV).

You will learn about the regulations that impact your systems and practice writing validation documents. You’ll leave ready to lead efficient, effective, and inspection-ready validation projects, whether you choose to follow a traditional waterfall or agile methodology.

The training camp is difficult and stimulating. This is a comprehensive three-day immersion in the validation process, including industry best practices and the latest technological advancements. Participants will perform hands-on validation activities through instructions, exercises and case scenarios.

Learning objectives

  • Understanding of how to comply with key FDA and international CSV regulations and guidelines, such as 21 CFR Part 11 and Annex 11
  • The purpose of each validation deliverable and the practical practice of creating each deliverable, including the validation plan, specification of requirements, test plan, validation tests (IQ, OQ, PQ), trace, test summary and validation report
  • Understanding of risk-based validation techniques and how to take advantage of these techniques to create effective yet compliant validation approaches
  • Appropriate validation strategies for many types of applications including Cloud / SaaS, COTS, spreadsheets and custom developed systems
  • Knowledge of best practices and inspector expectations for computer systems validation and software quality assurance (SQA) programs

Main topics covered:

AGENDA – Day 1

  • Module 1: Computer System Validation (CSV) Regulations at 12:30 p.m. EDT
    • FDA regulations and guidelines
    • Other regulations and directives (EMA, ICH, EU, MHRA, PIC / S)
    • Exercise: Explore the regulations using the website
  • Module 2: Computer System Validation Method and Templates 1:30 p.m. EDT
    • Validation, verification and qualification
    • Common SDLC
    • Model GAMP 5 “V”
    • COTS, Cloud, SaaS, PaaS, IaaS
    • Validation of the worksheet

Break 2:45 p.m. EDT 15 minutes

  • Module 3: 21 CFR Part 11 – 3:00 p.m. EDT
    • 21 CFR Part 11 Guidelines
    • Requirements for electronic records / signatures
    • Exercise: FDA Guidelines for ER / ES
  • Data Integrity and Governance – 4:00 p.m. EDT
  • End of session time: 5:00 p.m. EDT

AGENDA – Day 2

  • Module 4: Planning for Validation – 12:30 p.m. EDT
    • Validation Strategy Document
    • Components of the validation strategy
    • Justification of validation tests
    • Categorization of the GAMP 5 system
  • Module 5: Risk-Based Validation – 2:15 p.m. EDT
    • Risk assessment
    • Risk mitigation
    • Exercise: Writing the validation plan

Break – 3:00 p.m. EDT

  • Module 6: Requirements – 3:15 p.m. EDT
    • Requirements development
    • User Requirements Specification (URS)
    • Functional Requirements Specification (FRS)
    • Exercise: URS / FRS requirements interviews and writing
  • Module 7: System Design and Development – 3:40 p.m. EDT
    • System Design Configuration (SDS)
    • Configuration Management Specification (CMS)
  • Module 8: IQ, OQ, PQ Protocols and Execution – 4:00 p.m. EDT
    • Validation test process
    • Objective and content of the IQ
    • Objective and content of the OQ
    • Purpose and content of the PQ
  • Module 9: Validation test plan
    • Principles of validation testing
    • Testing techniques
    • Objective and content of the test plan
    • Exercise: Writing a test plan
  • Module 10: IQ, OQ, PQ protocols
    • Structure and content of the protocol
    • Objective proof
    • Test good writing practices
    • Test the good practices of the structure
    • Exercise: writing IQ / OQ / PQ
  • Module 11: Running Tests
    • Good test execution practices
    • Documentation of validation failure
    • Exercise: Running the validation test
  • End of session time: 5:00 p.m. EDT

AGENDA – Day 3

  • Module 12: Requirements Traceability Matrix (RTM) 12:30 p.m. EDT
    • Purpose and content of Trace Matrix
    • Exercise: writing the trace matrix
  • Module 13: Test and Validation Reports – 12:45 p.m. EDT
    • Objective and content of the test summary
    • Purpose and content of the validation report
    • Exercise: Writing the validation summary report
  • Module 14: Change Management 1:00 p.m. EDT
    • Maintaining validation status
    • Change control processes
    • Security and Access
    • Review of the audit trail
    • Incidence reports
    • Periodic review of the system
    • Module 15: System Logout at 2:00 p.m. EDT
    • Record keeping
    • The challenges of retirement

Break at 2:30 p.m. EDT 15 minutes

  • Module 16: Warning letters from the FDA at 2:45 p.m. EDT
    • Current trends in compliance and enforcement
    • Case Study: FDA Law Enforcement
    • Exercise: Be the consultant
  • Module 17: Q / A session and CSV exam at 4:00 p.m. EDT
    • Activity: Preparation for the exam
    • Final exam
    • Q&A session with the course instructor

End of session time: 5:00 p.m. EDT

For more information on this training, visit

         Laura Wood, Senior Press Manager
         [email protected]
         For E.S.T Office Hours Call 1-917-300-0470
         For U.S./CAN Toll Free Call 1-800-526-8630
         For GMT Office Hours Call +353-1-416-8900

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Gordon K. Morehouse