Instructor :
Carolyn Troiano

Webinar ID:
13747

Master Computer System Validation (CSV) in Just 3 Days – Ensure FDA Compliance & Boost Your Career!

In today’s rapidly evolving regulatory landscape, mastering Computer System Validation (CSV) is essential for maintaining compliance and preventing costly FDA findings.

This intensive 3-day virtual boot camp provides practical tools, expert insights, and hands-on exercises specifically designed for professionals in pharmaceutical, biotechnology, medical device, and other FDA-regulated industries.

Led by industry experts, this interactive training features real-world case studies, audit simulations, and actionable strategies to help you:

• • Eliminate FDA 483 citations and avoid compliance pitfalls.
  • Streamline validation processes with proven methods aligned with 21 CFR Part 11 and GAMP 5.
  • Enhance data integrity, minimize system failures, and confidently manage validation activities.

What You’ll Learn:

• • ✅ Core Principles of CSV:
    • • Ensure system efficiency, reliability, and compliance from day one.
• • ✅ Risk-Based Validation:
    • • Identify, assess, and mitigate risks proactively to avoid regulatory issues.
• • ✅ 21 CFR Part 11 & Data Integrity:
    • • Master FDA expectations for electronic records and signatures.
• • ✅ System Development Life Cycle (SDLC):
    • • Expert techniques for validation planning, testing, documentation, and execution.
• • ✅ Audit Readiness & Inspection Strategies:
    • • Practical tips to ensure your systems and documentation are always inspection-ready.
• • ✅ GAMP 5 Framework Mastery:
    • • Best practices for automated system validation in regulated environments.

Key Benefits:

• • 🎯 Interactive, hands-on exercises to build real-world expertise.
  • 🎯 Ready-to-use validation templates, checklists, and tools.
  • 🎯 “Think like an Auditor” simulation to build inspection confidence.
  • 🎯 Digital Certificate of Mastery post completing the session.

Join this power-packed, practical CSV training to future-proof your compliance strategy, enhance your professional value, and confidently navigate FDA regulations.

Register Today – Take Your CSV Expertise to the Next Level!

In today’s rapidly evolving digital landscape, ensuring the integrity, reliability, and compliance of computer systems in FDA-regulated environments is more critical than ever.

This comprehensive 3-day boot camp provides professionals with the knowledge, tools, and best practices to implement Computer System Validation (CSV) effectively while maintaining compliance with FDA, 21 CFR Part 11, and GAMP 5 guidelines.

Led by industry expert, this interactive training dives into real-world case studies, equipping participants with strategies to minimize system failures, enhance data integrity, and streamline validation processes.

Attendees will gain hands-on expertise in planning, testing, and managing validated systems, ensuring compliance across pharmaceutical, biotechnology, and medical device industries.

What You Will Learn:

• • Core Principles of CSV
    • • Understand the role of validation in ensuring system efficiency, reliability, and compliance.

• • Risk-Based Approach to Validation
    • • Learn how to assess and mitigate risks to prevent system failures and regulatory non-compliance.

• • 21 CFR Part 11 & Data Integrity
    • • Explore electronic records, electronic signatures, and FDA expectations for compliance.

• • System Development Life Cycle (SDLC) for CSV
    • • Master validation planning, execution, and documentation best practices.

• • Audit Readiness & Compliance Strategies
    • • Prepare for FDA inspections and audits by implementing effective validation policies and procedures.

• • GAMP 5 Framework
    • • Understand best practices for validating automated systems in regulated environments.

This boot camp is ideal for quality assurance professionals, IT specialists, compliance officers, and validation experts looking to enhance their expertise and ensure their systems meet FDA regulatory requirements.

Join us for this power-packed, interactive learning experience and take your CSV knowledge to the next level!

Register Today!

Ensuring compliance, data integrity, and system reliability in an FDA-regulated environment is more complex than ever.

With strict regulatory oversight and evolving validation requirements, organizations must adopt a risk-based, efficient approach to Computer System Validation (CSV)—or risk costly compliance failures.

This 3-day intensive boot camp is designed to help you cut through the confusion and master CSV with practical, real-world applications.

Unlike generic compliance courses, this training goes beyond theory, equipping you with industry-validated tools, templates, and strategies to build an inspection-ready validation framework.

Key Benefits:

• • Stay Audit-Ready
    • • Learn how to ensure your systems meet FDA, 21 CFR Part 11, and GAMP 5 compliance standards.

• • Reduce Risk & Downtime
    • • Implement risk-based validation strategies that prevent system failures and regulatory setbacks.

• • Practical, Hands-On Learning
    • • Work with real-world case studies, expert-led discussions, and actionable templates.

• • Industry Expert Insights
    • • Gain direct knowledge from Carolyn Troiano, a seasoned professional with years of hands-on experience.

• • Adapt to Changing Regulations
    • • Understand how FDA expectations are evolving and how to stay ahead of compliance trends.

Whether you’re implementing new systems, updating existing ones, or preparing for an audit, this boot camp will empower you with the expertise needed to streamline validation processes and ensure long-term compliance success.

Don’t leave compliance to chance—equip yourself with the skills to navigate CSV confidently!

Enroll Now!

Ensuring compliance, data integrity, and system reliability in an FDA-regulated environment is more complex than ever.

With strict regulatory oversight and evolving validation requirements, organizations must adopt a risk-based, efficient approach to Computer System Validation (CSV)—or risk costly compliance failures.

This 3-day intensive boot camp is designed to help you cut through the confusion and master CSV with practical, real-world applications.

Unlike generic compliance courses, this training goes beyond theory, equipping you with industry-validated tools, templates, and strategies to build an inspection-ready validation framework.

Key Benefits:

• • Stay Audit-Ready
    • • Learn how to ensure your systems meet FDA, 21 CFR Part 11, and GAMP 5 compliance standards.

• • Reduce Risk & Downtime
    • • Implement risk-based validation strategies that prevent system failures and regulatory setbacks.

• • Practical, Hands-On Learning
    • • Work with real-world case studies, expert-led discussions, and actionable templates.

• • Industry Expert Insights
    • • Gain direct knowledge from Carolyn Troiano, a seasoned professional with years of hands-on experience.

• • Adapt to Changing Regulations
    • • Understand how FDA expectations are evolving and how to stay ahead of compliance trends.

Whether you’re implementing new systems, updating existing ones, or preparing for an audit, this boot camp will empower you with the expertise needed to streamline validation processes and ensure long-term compliance success.

Don’t leave compliance to chance—equip yourself with the skills to navigate CSV confidently!

Enroll Now!

Day 1: Foundations of Computer System Validation (4 Hours)

Module 1: Introduction to CSV & System Development Life Cycle (SDLC)

• • Regulatory Landscape & Compliance
    • FDA Compliance & Guidance
    • International Regulations (EMA, EU, MHRA)
  • Exercise: Exploring FDA regulations using the gov website

Module 2: CSV Methods & Models

• • Understanding GxP Systems
  • Computer System Validation (CSV) vs. Verification vs. Qualification
  • Common SDLC Methodologies
  • GAMP 5 “V” Model for validation

Module 3: Software & Services in CSV

• • Computer Off-the-Shelf (COTS) Software
  • Cloud Systems & SaaS Validation
  • FDA’s “Case for Quality” Initiative
  • Software as a Service (SaaS), Platform as a Service (PaaS), Infrastructure as a Service (IaaS)
  • Single Sign-On (SSO) & Authentication
  • Medical Devices & Software as a Medical Device (SaaMD)
  • Software Quality Assurance (SQA) Plan
  • Spreadsheet & Mobile Device Validation
  • Case Study: Cloud SaaS Validation

Module 4: 21 CFR Part 11 & FDA’s Electronic Records/Signatures (ER/ES) Guidance

• • Understanding 21 CFR Part 11
  • Key Electronic Records & Signatures (ER/ES) Requirements
  • Exercise: Analyzing FDA’s ER/ES Guidance
  • Vendor Audit Best Practices

Module 5: Data Integrity & Governance in CSV

• • Data Life Cycle Approach
  • Ensuring Data Integrity & Governance Compliance

Q&A Session: Open discussion with the presenter to clarify key concepts.

Day 2: Advanced Validation Strategies (4 Hours)

Module 6: CSV Planning & Risk-Based Approach

• • Validation Strategy Document (VSD) & Key Components
  • GAMP 5 System Categorization
  • Risk-Based Validation Testing Approach

Module 7: Key CSV Supporting Components

• • Good Documentation Practices (GDPs) Training
  • Organizational Change Management (OCM) in CSV
  • Developing Effective CSV Policies & Procedures

Module 8: Risk-Based Computer System Validation

• • Performing Risk Assessments
  • Risk Mitigation Strategies
  • Exercise: Writing a Validation Master Plan (VMP)

Module 9: System Requirements & Design

• • Developing System Requirements Documentation
    • User Requirements Specification (URS)
    • Functional Requirements Specification (FRS)
  • Exercise: Conducting Stakeholder Interviews & Writing URS/FRS
  • System Design & Configuration Management Specification (SDS/CMS)

Module 10: IQ, OQ, PQ – Test Planning & Execution

• • Understanding IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification)
  • Test Execution & Reporting
  • Exercise: Writing IQ, OQ, PQ Test Protocols
  • CSV Test Summary Report Best Practices

Q&A Session: Open discussion with the presenter to reinforce concepts.

Day 3: Validation Lifecycle & Compliance Maintenance (4 Hours)

Module 11: Requirements Traceability Matrix (RTM) & Validation Reports

• • RTM Purpose & Structure
  • Exercise: Writing a Requirements Traceability Matrix (RTM)

Module 12: Validation & System Release Reports

• • Validation Summary Report (VSR) & Release Notification
  • Exercise: Writing a VSR Report

Module 13: Change Management & System Maintenance

• • Maintaining Validation Status & Change Control Processes
  • Security, Access Control & Audit Trail Review
  • Incident Reporting & Periodic System Review
  • Disaster Recovery & Business Continuity Planning

Module 14: System Retirement & Data Migration

• • Challenges in System Retirement & Data Migration
  • Legacy System Integration & Record Retention

Module 15: FDA Compliance & Inspection Readiness

• • Understanding Regulatory Trends & FDA Enforcement Actions
  • FDA Inspection & Audit Preparation
  • Exercise: “Be the Consultant” – Simulating a Data Integrity Audit Scenario

Final Q&A Session: Open discussion with the presenter to address final queries.

Bonus:

📌 Independent Study & Practical Exercises

Participants can complete the following exercises at their own pace. If completed before the end of the boot camp, they may ask questions during any Q&A session.

• • Exploring Regulations using the FDA Website
  • ER/ES Compliance & FDA Guidance Analysis
  • Validation Master Plan (VMP) Writing
  • Stakeholder Interviews & Writing URS/FRS
  • IQ, OQ, PQ Test Protocol Writing
  • Requirements Traceability Matrix (RTM) Writing
  • Validation Summary Report (VSR) Writing
  • Data Integrity Audit – Be the Consultant Exercise

🎓 CSV Final Exam: 100-question assessment to reinforce key concepts, available for completion at the attendee’s discretion.

This agenda ensures a structured, hands-on, and interactive learning experience, giving participants a practical and compliance-driven approach to mastering Computer System Validation (CSV).

💡 Want a tailored version of this training for your team?

Contact support@compliancemeet.com for customized corporate sessions!

Day 1: Foundations of Computer System Validation (4 Hours)

Module 1: Introduction to CSV & System Development Life Cycle (SDLC)

• • Regulatory Landscape & Compliance
    • FDA Compliance & Guidance
    • International Regulations (EMA, EU, MHRA)
  • Exercise: Exploring FDA regulations using the gov website

Module 2: CSV Methods & Models

• • Understanding GxP Systems
  • Computer System Validation (CSV) vs. Verification vs. Qualification
  • Common SDLC Methodologies
  • GAMP 5 “V” Model for validation

Module 3: Software & Services in CSV

• • Computer Off-the-Shelf (COTS) Software
  • Cloud Systems & SaaS Validation
  • FDA’s “Case for Quality” Initiative
  • Software as a Service (SaaS), Platform as a Service (PaaS), Infrastructure as a Service (IaaS)
  • Single Sign-On (SSO) & Authentication
  • Medical Devices & Software as a Medical Device (SaaMD)
  • Software Quality Assurance (SQA) Plan
  • Spreadsheet & Mobile Device Validation
  • Case Study: Cloud SaaS Validation

Module 4: 21 CFR Part 11 & FDA’s Electronic Records/Signatures (ER/ES) Guidance

• • Understanding 21 CFR Part 11
  • Key Electronic Records & Signatures (ER/ES) Requirements
  • Exercise: Analyzing FDA’s ER/ES Guidance
  • Vendor Audit Best Practices

Module 5: Data Integrity & Governance in CSV

• • Data Life Cycle Approach
  • Ensuring Data Integrity & Governance Compliance

Q&A Session: Open discussion with the presenter to clarify key concepts.

Day 2: Advanced Validation Strategies (4 Hours)

Module 6: CSV Planning & Risk-Based Approach

• • Validation Strategy Document (VSD) & Key Components
  • GAMP 5 System Categorization
  • Risk-Based Validation Testing Approach

Module 7: Key CSV Supporting Components

• • Good Documentation Practices (GDPs) Training
  • Organizational Change Management (OCM) in CSV
  • Developing Effective CSV Policies & Procedures

Module 8: Risk-Based Computer System Validation

• • Performing Risk Assessments
  • Risk Mitigation Strategies
  • Exercise: Writing a Validation Master Plan (VMP)

Module 9: System Requirements & Design

• • Developing System Requirements Documentation
    • User Requirements Specification (URS)
    • Functional Requirements Specification (FRS)
  • Exercise: Conducting Stakeholder Interviews & Writing URS/FRS
  • System Design & Configuration Management Specification (SDS/CMS)

Module 10: IQ, OQ, PQ – Test Planning & Execution

• • Understanding IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification)
  • Test Execution & Reporting
  • Exercise: Writing IQ, OQ, PQ Test Protocols
  • CSV Test Summary Report Best Practices

Q&A Session: Open discussion with the presenter to reinforce concepts.

Day 3: Validation Lifecycle & Compliance Maintenance (4 Hours)

Module 11: Requirements Traceability Matrix (RTM) & Validation Reports

• • RTM Purpose & Structure
  • Exercise: Writing a Requirements Traceability Matrix (RTM)

Module 12: Validation & System Release Reports

• • Validation Summary Report (VSR) & Release Notification
  • Exercise: Writing a VSR Report

Module 13: Change Management & System Maintenance

• • Maintaining Validation Status & Change Control Processes
  • Security, Access Control & Audit Trail Review
  • Incident Reporting & Periodic System Review
  • Disaster Recovery & Business Continuity Planning

Module 14: System Retirement & Data Migration

• • Challenges in System Retirement & Data Migration
  • Legacy System Integration & Record Retention

Module 15: FDA Compliance & Inspection Readiness

• • Understanding Regulatory Trends & FDA Enforcement Actions
  • FDA Inspection & Audit Preparation
  • Exercise: “Be the Consultant” – Simulating a Data Integrity Audit Scenario

Final Q&A Session: Open discussion with the presenter to address final queries.

Bonus:

📌 Independent Study & Practical Exercises

Participants can complete the following exercises at their own pace. If completed before the end of the boot camp, they may ask questions during any Q&A session.

• • Exploring Regulations using the FDA Website
  • ER/ES Compliance & FDA Guidance Analysis
  • Validation Master Plan (VMP) Writing
  • Stakeholder Interviews & Writing URS/FRS
  • IQ, OQ, PQ Test Protocol Writing
  • Requirements Traceability Matrix (RTM) Writing
  • Validation Summary Report (VSR) Writing
  • Data Integrity Audit – Be the Consultant Exercise

🎓 CSV Final Exam: 100-question assessment to reinforce key concepts, available for completion at the attendee’s discretion.

This agenda ensures a structured, hands-on, and interactive learning experience, giving participants a practical and compliance-driven approach to mastering Computer System Validation (CSV).

💡 Want a tailored version of this training for your team?

Contact support@compliancemeet.com for customized corporate sessions!

Everybody benefits from watching this. Even better when done as a group!

• • Quality Assurance And Compliance Professionals In Life Sciences
  • Regulatory Affairs Specialists Ensuring FDA CSV Compliance
  • IT And System Validation Professionals In Regulated Industries
  • Pharmaceutical And Biotechnology Professionals Managing GxP Systems
  • Medical Device Professionals Handling Software Validation Processes
  • CSV Consultants And Auditors Preparing For FDA Inspections
  • Clinical Research And Data Integrity Compliance Experts
  • Manufacturing And Operations Leaders Overseeing Validated Systems

Everybody benefits from watching this. Even better when done as a group!

• • Quality Assurance And Compliance Professionals In Life Sciences
  • Regulatory Affairs Specialists Ensuring FDA CSV Compliance
  • IT And System Validation Professionals In Regulated Industries
  • Pharmaceutical And Biotechnology Professionals Managing GxP Systems
  • Medical Device Professionals Handling Software Validation Processes
  • CSV Consultants And Auditors Preparing For FDA Inspections
  • Clinical Research And Data Integrity Compliance Experts
  • Manufacturing And Operations Leaders Overseeing Validated Systems