Computer System Validation Professional Certificate Course

This course is designed to completely 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 gain hands-on practice writing validation documents. You will leave ready to lead efficient, effective, inspection–ready validation projects, whether you choose to follow a traditional waterfall or agile methodology.

Boot camp is tough and challenging. It is a three-day complete immersion in the validation process, including industry best practices and more recent advances in technology. Participants will complete hands-on validation activities through instruction, exercises, and case scenarios.

Registration Cost Includes:
  • Checklist of documents and the direction for how to create
  • Course binder
  • Many exercises on Validation Plan, the Requirements Traceability Matrix, and the Validation Summary Report.
  • Training Certificate

Please bring a laptop to boot camp. You will need internet access, spreadsheet and word processing applications and a PDF reader.

AGENDA - Day 1

Module 1: Computer System Validation (CSV) Regulations 12:30 PM EDT

  • FDA Regulations and Guidance
  • Other Regulations and Guidance (EMA, ICH, EU, MHRA, PIC/S)
  • Exercise: Exploring the Regulations using the fda.gov website

Module 2: Computer System Validation Method and Models 1:30 PM EDT

  • Validation, verification, and qualification
  • Common SDLCs
  • GAMP 5 “V” Model
  • COTS, Cloud, SaaS, PaaS, IaaS
  • Spreadsheet Validation

Break 02:45 PM EDT 15 mins

Module 3: 21 CFR Part 11 - 03:00 PM EDT

  • 21 CFR Part 11 Guidance
  • Electronic records/signatures requirements
  • Exercise: FDA Guidance for ER/ES

Data Integrity and Governance - 04:00 PM EDT

Session End Time : 05:00 PM EDT

AGENDA – Day 2

Module 4: Validation Planning - 12:30 PM EDT

  • Validation Strategy Document
  • Validation Strategy Components
  • Rationale for Validation Testing
  • GAMP 5 System Categorization

Module 5: Risk-Based Validation - 02:15 PM EDT

  • Risk assessment
  • Risk mitigation
  • Exercise: Validation Plan writing

Break - 03:00 PM EDT

Module 6: Requirements - 03:15 PM EDT

  • Requirements development
  • User Requirements Specification (URS)
  • Functional Requirements Specification (FRS)
  • Exercise: Requirements Interviews and URS/FRS writing

Module 7: System Design and Development - 03:40 PM EDT

  • System Design Configuration (SDS)
  • Configuration Management Specification (CMS)

Module 8: IQ, OQ, PQ Protocols and Execution - 04:00 PM EDT

  • Validation testing process
  • IQ purpose and contents
  • OQ purpose and contents
  • PQ purpose and contents

Module 9: Validation Testing Plan

  • Principles of validation testing
  • Testing techniques
  • Testing Plan purpose and contents
  • Exercise: Testing Plan writing

Module 10: IQ, OQ, PQ Protocols

  • Protocol structure and contents
  • Objective evidence
  • Test writing best practices
  • Test structure best practices
  • Exercise: IQ/OQ/PQ writing

Module 11: Test Execution

  • Test execution best practices
  • Validation failure documentation
  • Exercise: Validation test execution

Session End Time : 05:00 PM EDT

AGENDA – Day 3

Module 12: Requirements Traceability Matrix (RTM) 12:30 PM EDT

  • Trace Matrix purpose and contents
  • Exercise: Trace Matrix writing

Module 13: Test and Validation Reports - 12:45 PM EDT

  • Test Summary purpose and contents
  • Validation Report purpose and contents
  • Exercise: Validation Summary Report writing

Module 14: Change Management 01:00 PM EDT

  • Maintaining validation status
  • Change control processes
  • Security and Access
  • Audit Trail Review
  • Incidence Reporting
  • Periodic System Review

Module 15: System Retirement 02:00 PM EDT

  • Record retention
  • Retirement challenges

Break at 02:30 PM EDT 15 mins

Module 16: FDA Warnings Letters 02:45 PM EDT

  • Current Trends in Compliance and Enforcement
  • Case Study: FDA enforcement
  • Exercise: Be the Consultant

Module 17: Q/A Session & CSV Exam 04:00 PM EDT

  • Activity: Exam Preparation
  • Final Exam
  • Q/A Session with the Course Instructor

Session End Time : 05:00 PM EDT

Learning Objectives

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

·      The purpose of each validation deliverable and hands-on practice creating each deliverable, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Trace Matrix, Test Summary, and Validation Report

·      Comprehension of risk-based validation techniques and how to leverage these techniques to create efficient yet compliant validation approaches

·      Appropriate validation strategies for many types of applications, including Cloud/SaaS, COTS, spreadsheets, and custom developed systems

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

Who Should Attend Computer System Validation Training

Personnel in the following roles will benefit:

  • Information Technology Analysts
  • Information Technology 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 Submissions 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 System/Application Testers
  • Vendors responsible for software development, testing and maintenance
  • Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance

Attendee Question from our last CSV Training

What should be done if there is no audit trial capability for a system?

Faculty Answer If there is no audit trial capability for a system then that does not get you off the hook with FDA.You have to produce some evidence that you know what changes you can make where you show objectively the entire history of the record.

Participant Testimonials

The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterwards about it. Thank you WCS for bringing on board such wonderful experts.

Robert Friedland , IT Manager NUTEK BRAVO, LLC.

For me the training was useful in order to clarify requirements from the FDA in regards to the expectation for the Computerised System Validation process. I will definitely recommend this course to others.

Yorlehin Robiou , Quality Systems and Compliance Manager, Jabil Healthcare

Choose a Purchase Options


$1,295

Early Bird One Dial-in One Attendee - Live

Early Bird $1295 Regular Price $1985

You get one log-in for the live virtual seminar for one participant, presentation materials , Certificate and the opportunity to ask questions by phone and email.

$3,995

Group-Max. 5 Attendees - Live + 12 month access

You get Group log-in for the live virtual seminar for 5 participants, presentation materials , Certificate and the opportunity to ask questions by phone and email. On Demand Recorded Access is Included for 12 month for the Group.

$1,899

Recorded Access Single Participant

You'll have access to single log-in for an archived recording for 12 months of the entire 3 day virtual seminar including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$3,998

Recorded Access Group

12 month multiple user access

You'll have 12 month access to group log-in for an archived recording of the entire 3 day virtual seminar including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session


Faculty Carolyn Troiano

Faculty Carolyn Troiano

  • Midlothian, Virginia, United States

Award winning FDA Compliance Speaker for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity.

My experience includes 34+ years in IT/ Business, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries.

My successes include building and managing teams and business units at multiple “greenfield” sites in the pharmaceutical, biotechnology and IT consulting industries, as well as in the public sector. I have weathered numerous layoffs, mergers and acquisitions, and demonstrated my very strong leadership skills in helping staff get through difficult times.