Computer System Validation (CSV) 3-Day Training Program (September 21-23, 2022) –


DUBLIN–(BUSINESS WIRE)–Computer System Validation (CSV) Training has been added to from offer.

Learn Computer System Validation Professional Certificate Program Online

This Computer System Validation course is designed to fully immerse you in Computer System Validation (CSV) principles, methods, and best practices. You will learn about the regulations that impact your systems and practice writing validation documents. You’ll walk away ready to conduct efficient, effective, and inspection-ready validation projects, whether you choose to follow a traditional waterfall or agile method.

Boot camp is tough and challenging. This is a full three-day immersion into 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.

The registration cost includes:

  • Document checklist and creation instructions

  • Course binder

  • Many exercises on the validation plan, the requirements traceability matrix and the validation summary report.

  • Training certificate

Learning objectives

  • Understanding of how to comply with key FDA regulations and guidelines and international CSV standards, such as 21 CFR Part 11 and Annex 11

  • The purpose of each validation deliverable and the practical practice of creating each deliverable, including validation plan, requirements specification, test plan, validation tests (IQ, OQ, PQ), monitoring, test summary and validation report

  • Understanding of risk-based validation techniques and how to leverage these techniques to create effective yet compliant validation approaches

  • Appropriate validation strategies for many types of applications, including Cloud/SaaS, COTS, spreadsheets, and custom-built systems

  • Awareness of best practices and inspector expectations for computer system validation and software quality assurance (SQA) programs

Who should attend:

  • Information technology analysts

  • IT developers and testers

  • Software Quality Assurance Professionals

  • QC/QA managers and analysts

  • Analytical chemists

  • Compliance and Audit Managers

  • Laboratory managers

  • Automation Analysts

  • Manufacturing specialists and managers

  • Supply chain specialists and managers

  • Regulatory Affairs Specialists

  • Regulatory Submission Specialists

  • Risk management professionals

  • Clinical data analysts

  • Clinical Data Managers

  • Clinical Trial Sponsors

  • Computer system validation specialists

  • GMP Training Specialists

  • Business Stakeholders/Subject Matter Experts

  • Business systems/application testers

  • Suppliers responsible for software development, testing and maintenance

  • Suppliers and consultants working in the life sciences industry who are involved in the implementation, validation and compliance of IT systems

Main topics covered:

AGENDA – Day 1

Module 1: Computer Systems Validation (CSV) Regulations 12:30 p.m. EDT

  • FDA regulations and guidelines

  • Other regulations and directives (EMA, ICH, EU, MHRA, PIC/S)

  • Exercise: Explore regulations using the website

Module 2: Computer System Validation Method and Models 1:30 p.m. EDT

  • Validation, verification and qualification

  • Common SDLCs

  • GAMP 5 “V” model

  • COTS, Cloud, SaaS, PaaS, IaaS

  • Spreadsheet Validation

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

Session end time: 5:00 p.m. EDT

AGENDA – Day 2

Module 4: Validation Planning – 12:30 p.m. EDT

  • Validation strategy document

  • Validation Strategy Components

  • 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: Requirements interviews and URS/FRS writing

Module 7: System Design and Development – 3:40 p.m. EDT

  • System Design Setup (SDS)

  • Configuration Management Specification (CMS)

Module 8: IQ, OQ, PQ Protocols and Execution – 4:00 p.m. EDT

  • Validation testing process

  • Purpose and content of the IQ

  • Objective and content of the OQ

  • Objective and content of the PQ

Module 9: Validation Test Plan

  • Principles of validation tests

  • Testing Techniques

  • Objective and content of the test plan

  • Exercise: writing the test plan

Module 10: IQ, OQ, PQ Protocols

  • Structure and content of the protocol

  • Objective evidence

  • Test writing best practices

  • Test Structure Best Practices

  • Exercise: IQ/OQ/PQ writing

Module 11: Executing Tests

  • Test Execution Best Practices

  • Documentation of validation failures

  • Exercise: Running the validation test

Session end time: 5:00 p.m. EDT

AGENDA – Day 3

Module 12: Requirements Traceability Matrix (RTM) 12:30 p.m. EDT

  • Purpose and content of the trace matrix

  • Exercise: writing a trace matrix

Module 13: Testing and Validation Reports – 12:45 p.m. EDT

  • Purpose 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

  • Maintain validation status

  • Change control processes

  • Security and Access

  • Audit trail review

  • Incident reports

  • Periodic System Review

Module 15: System Removal 2:00 p.m. EDT

  • Records retention

  • Retirement challenges

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

Module 16: FDA Warning Letters 2:45 p.m. EDT

  • Current trends in compliance and enforcement

  • Case Study: FDA Enforcement

  • Exercise: Be the consultant

Module 17: Q&A Session and CSV Exam 4:00 p.m. EDT

  • Activity: Preparation for the exam

  • Final exam

  • Q&A session with the course instructor

Session end time: 5:00 p.m. EDT

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