Seminar Overview


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Available in days
days after you enroll

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

Who Should Attend

IT, QA, & Business Managers and Professionals who need to:

  • Manage or participate on computer system projects requiring validation
  • Create or approve CSV project deliverables, such as requirements documents, validation protocols (IQ, OQ, PQ), Test Plans, and Test Reports.
  • Understand the process of computer system validation
  • Author, implement, or upgrade CSV policies and procedures that utilize a risk-based approach to meeting the latest regulatory expectations
  • Understand the FDA and international regulatory landscape around CSV.
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 Certification

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

Hands-On Training

A course designed to completely immerse you in computer system validation. This course delivers comprehension of the regulations impacting your systems and hands-on practice writing validation documents. You will leave ready to lead efficient, effective, inspection– ready validation projects.

AGENDA - Day 1

Module 1: Regulation for CSV

  • 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: Validation Method and Models

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

Module 3: 21 CFR Part 11

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

Module 4: Validation Planning

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

Module 5: Risk-Based Validation

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

Module 6: Requirements

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

AGENDA – Day 2

Module 7: System Design and Development

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

Module 8: IQ, OQ, PQ Overview

  • 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

AGENDA – Day 3

Module 12: Trace Matrices

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

Module 13: Test and Validation Reports

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

Module 14: Change Management

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

Module 15: System Retirement

  • Record retention
  • Retirement challenges

Module 16: FDA Warnings Letters

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

Module 17: CSV Exam

  • Activity: Exam Preparation
  • Final Exam

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

Course Description

Boot camp is tough and challenging. It is a three-day complete immersion in the validation process. Participants will work in focused teams to complete hands-on validation activities through instruction, exercises, and case scenarios. The course moves quickly and participants will change gears often to keep interest high and accommodate multiple learning styles. A balance of instructor lectures, reading materials, exercises and case studies keeps energy levels high and challenges the participants.

Why Should You Attend:

We have used our real-world experience to design a computer system validation course that not only meets FDA, ICH, and Eudralex expectations for risk-based validation, but also prepares you to implement these practices in your company. The standard operating procedures and validation templates used in class have already been proven at other companies.

We are focused on your comprehension and application of the CSV techniques that will result in efficient, effective, and inspection-ready validation initiatives.

Faculty Carolyn Troiano

Faculty Carolyn Troiano

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.

Choose a Purchase Options


$1,950

Corporate On Demand Access

For 1 Location

You'll have access for an archived recording of the entire 3 Days Virtual Seminar. 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