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Computer System Validation Masterclass

15-Hour Modular Certification Course

REGISTER FOR THE COURSE

US $1200 per learner

30-Days Unlimited Streaming Access

  • Course Director
    Carolyn Troiano
  • Course ID
    TF3541
  • Streaming Access +
    Modular Continued Learning
  • Ask The Expert
    Included
  • Presentation Handout
    & Templates
  • Assessment &
    Certification Included

This course helps teams convert CSV requirements into practical validation decisions, documented deliverables, risk-based testing rationale, and life-cycle controls that can withstand inspection and audit scrutiny.

 

Registration Includes:
– Checklist of documents and the direction for how to create
– Course Material
– Exercises to get a grasp on practical approaches.
– Final Assessment
– Training Certification
– Expert-led 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.
EXERCISES: Independent Study
The following exercises will be included in the course content and can be completed at each attendee’s discretion.

Exercise 1: Exploring the Regulations using the fda.gov website
Exercise 2: FDA Guidance for ER/ES
Exercise 3: Validation Master Plan (VMP) Writing
Exercise 4: Interviews and URS/FRS Writing
Exercise 5: IQ, OQ, PQ Test Protocol Writing
Exercise 6: RTM Writing
Exercise 7: VSR Writing
Exercise 8: Be the Consultant – Example of a Data Integrity Audit by FDA at a pharmaceutical manufacturer

About the Course

Computer system validation remains a core control for systems used to manufacture, test, distribute, collect, analyze, manage, transfer, or report regulated data. For FDA-regulated organizations, CSV is not only a documentation activity. It is the method used to demonstrate that GxP systems are planned, tested, controlled, and maintained in a way that supports data integrity, product quality, and patient or consumer safety.


This course addresses the full validation life cycle, from identifying GxP systems and defining validation rationale to planning, requirements, testing, traceability, reporting, change control, periodic review, disaster recovery, business continuity, retirement, and vendor oversight. It also connects CSV execution with electronic records and electronic signatures expectations under 21 CFR Part 11 and international expectations including Annex 11.


The material is organized around risk-based validation, using system size, complexity, business criticality, GAMP 5 category, and failure risk to determine validation scope. It is designed for teams responsible for creating, approving, maintaining, or auditing CSV deliverables across regulated operations, including IT, Quality, laboratories, manufacturing, clinical, supply chain, regulatory, and business functions.

Build stronger CSV judgment across regulated systems

CSV decisions increasingly depend on risk rationale, data integrity exposure, vendor oversight, and life-cycle control. This course strengthens the ability to classify GxP systems, justify testing depth, maintain validation status, and prepare documentation that aligns with FDA and international expectations.

A sequential build from regulation to execution

The structure moves from regulatory context and validation methodology into planning, requirements, testing, traceability, reporting, maintenance, retirement, and inspection readiness. Each stage builds on the prior one so participants can connect CSV documentation, risk decisions, and operational controls into a complete life-cycle approach.

Key Areas Covered

  • GxP system identification and validation scope determination
  • SDLC methodology applied to regulated computer systems
  • Risk-based validation rationale using size, complexity, criticality, GAMP 5 category, and failure impact
  • Validation planning, requirements, test strategy, execution, summary, and reporting controls
  • IQ, OQ, PQ protocol development and test evidence management
  • Requirements traceability from specification through release decision
  • Electronic records and electronic signatures compliance under 21 CFR Part 11 and Annex 11
  • Data integrity controls across structured and unstructured regulated data
  • Change management, access control, audit trail review, incident handling, and periodic review
  • Vendor audit expectations for hardware, software, tools, utilities, and services

Who Must Attend

  • Information Technology (IT) Validation Leaders
  • Quality Assurance (QA) Managers
  • Quality Control (QC) Laboratory Managers
  • Regulatory Affairs (RA) Specialists
  • Research & Development (R&D) System Owners
  • Manufacturing Operations Managers
  • Supply Chain Management Leaders
  • Clinical Data Management Teams
  • Compliance and Audit Managers
  • Computer System Validation Specialists

Course Agenda

MODULE 1

CSV Foundations, Regulatory Context, and Validation Planning

  • FDA, EMA, EU, and MHRA expectations for regulated computer systems
  • GxP system identification and validation applicability
  • CSV, verification, qualification, and SDLC methodology
  • GAMP 5 V-model and system categorization
  • Validation strategy development and planning rationale
  • Good documentation practices for CSV records
  • Training, organizational change, and procedural support
  • Risk assessment and validation master planning

MODULE 2

Requirements, Testing, Traceability, and Clinical System Controls

  • Clinical trial system records and Trial Master File controls
  • Requirements development for users and system functions
  • URS and FRS writing practices
  • Design and configuration management documentation
  • IQ, OQ, and PQ protocol planning
  • Test execution and evidence handling
  • Requirements Traceability Matrix construction
  • Test summary and validation reporting

MODULE 2

Life-Cycle Control, Inspection Readiness, and System Retirement

  • Validation Summary Report and release notification
  • Maintaining validation status after release
  • Change control and system security practices
  • Audit trail review and incident reporting
  • Periodic system review and continued control
  • Disaster recovery and business continuity planning
  • Record retention, retirement, legacy systems, and data migration
  • FDA warning letter trends and inspection readiness
COURSE DIRECTOR

Carolyn Troiano

Carolyn Troiano brings more than 35 years of CSV experience across pharmaceutical, medical device, animal health, tobacco, and other FDA-regulated environments. Her background includes validation program development, large-scale IT implementation work, and direct involvement with industry and FDA representatives on 21 CFR Part 11, giving this course strong practical grounding.

If you would like to request a Proforma invoice to sign up for this course. please click here

Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

Testimonials

“The masterclass was fantastic, both I and the QA Manager loved it and had extensive conversation afterwards about it. Thank you TalkFDA for bringing on board such wonderful expert”
- General Manager - Quality Assurance
“For me the training was useful in order to clarify requirements from the FDA in regards to the expectation for the Computerized System Validation process. I will definitely recommend this course to others. ”
- Manager – QA IT
“Among the best training our team has ever attended. Well organized, full of good tips, actually provided useful information. The speaker clearly had appropriate experience. This course should be conducted regularly.”
- Director, Quality

Your TalkFDA Seminar Experience

When you reserve your seat, everything is organized for you — from access to certification from one place.

1. Confirmation
You receive a confirmation email and your course appears instantly in your TalkFDA dashboard.

2. Your Course Hub
Your TalkFDA course page becomes your central hub where you can watch the course, access materials, and manage your learning.

3. Access course materials
The presentation handout and other materials can be downloaded inside the Course Player. You could use Discussion feature there to ask your questions.

4. Watch The Streaming and Complete your Course
The course playback will be available on the same course page. You could pause and continue or you can revisit important sections.
5. Earn Your Certificate
Complete the course and your certificate is unlocked automatically in your learning history.

The challenge with training is rarely signing up. It’s what happens afterward, when access, materials, & certification aren’t accessible from one place.
With TalkFDA Courses, Everything you need Live in One Place.
Simple. Organized. Professional.
Go ahead and Take the Course with confidence.

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