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Recorded Webinar

Risk-Based CSV/CSA for Modern GxP Systems: Making Defensible Validation Decisions in Practice

A two-day, risk-based framework for CSV/CSA and GAMP® 5 validation decisions on modern GxP systems — cloud, SaaS, configurable, and AI-enabled platforms — built for inspection readiness.

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3 hours/day (2-day course)
Carolyn Troiano

Instructor

Carolyn Troiano

Computer System Validation (CSV) & FDA Compliance Expert

What You'll Learn

Understand what FDA's CSA approach means in practice and how it differs from traditional CSV
Learn how to apply risk-based thinking to reduce unnecessary validation activities while maintaining compliance
Gain confidence in making and defending validation decisions during inspections and audits
Discover practical methods for validating cloud, SaaS, configurable, and AI-enabled systems
Improve validation efficiency by focusing resources on functions that impact patient safety, product quality, and data integrity
Learn how to leverage supplier documentation without compromising regulatory expectations
Develop inspection-ready validation strategies that withstand FDA, EMA, MHRA, and customer scrutiny
Strengthen your understanding of GAMP® 5, CSA, data integrity, and modern validation best practices
Participate in hands-on exercises that demonstrate how to apply risk-based validation concepts to real-world GxP systems
Leave with practical tools, templates, and decision-making frameworks that can be immediately applied within your organization

About the event

About this event

The regulatory landscape has shifted from documentation-heavy Computer System Validation (CSV) toward risk-based Computer Software Assurance (CSA), placing greater emphasis on critical thinking, intended use, patient safety, product quality, and evidence-based decision-making. Organizations must now demonstrate not only that systems are validated, but that validation decisions are scientifically justified, risk-based, and defensible during inspections.

This intensive two-day course provides a practical framework for applying CSV, CSA, GAMP® 5 principles, and quality risk management to modern GxP systems, including cloud, SaaS, configurable, and AI-enabled platforms. Attendees will learn how to determine the appropriate level of validation effort, focus testing where it matters most, leverage vendor documentation appropriately, and maintain systems in a continuous state of compliance. The course emphasizes inspection readiness, practical application, and regulatory-defensible decisions rather than excessive documentation.

This is a two-day course: Day 1 (Sept 10) covers Foundations of Modern CSV and CSA; Day 2 (Sept 11) covers Defensible Validation Decisions in Practice. Each day runs 11:00 AM - 2:00 PM Eastern Time US (3:00 PM - 6:00 PM GMT).

Code: FDB3244

Curriculum

Evolution from Traditional CSV to FDA's CSA Approach
15 min
Regulatory Expectations for Computerized Systems in GxP Environments
15 min
Understanding Intended Use and Fitness for Purpose
15 min
Applying Critical Thinking to Validation Activities
15 min
Risk-Based Validation Principles and Testing Strategies
15 min
GAMP® 5 and GAMP® 5 2nd Edition Concepts
15 min
Determining System Criticality, Complexity, and Risk
15 min
Validation Planning and Rationale Development
15 min
Requirements Management and Traceability
15 min
Leveraging Supplier Assessments and Vendor Documentation
15 min
Validation Approaches for SaaS, Cloud, and Configurable Systems
15 min
Inspection Expectations and Common Validation Deficiencies
15 min

Requirements

  • Quality Assurance Departments and Validation/CSV Practitioners
  • Applicable to IT and Digital Transformation Leaders, System Owners, and Data Integrity Specialists
  • Relevant to Compliance Departments, AI Governance Teams, and Regulatory Affairs Departments

Who Should Attend

This course is designed for Quality Assurance Departments, Validation and CSV Practitioners, IT and Digital Transformation Leaders, System Owners, Data Integrity Specialists, Compliance Departments, AI Governance Teams, Regulatory Affairs Departments, and everyone responsible for maintaining compliant and validated cloud-based and AI-enabled systems. It will also benefit vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance, as well as those in software development companies who support the life science industries.

Areas Covered

Evolution from traditional CSV to FDA’s CSA approach
Regulatory expectations for computerized systems in GxP environments
Understanding intended use and fitness for purpose
Applying critical thinking to validation activities
Risk-based validation principles and testing strategies
GAMP® 5 and GAMP® 5 2nd Edition concepts
Determining system criticality, complexity, and risk
Validation planning and rationale development
Requirements management and traceability
Leveraging supplier assessments and vendor documentation
Validation approaches for SaaS, cloud, and configurable systems
Inspection expectations and common validation deficiencies
Applying CSA to modern software development approaches
Agile, DevOps, and continuous deployment considerations
Risk-based testing: unscripted, scripted, and exploratory testing
Validation of AI-enabled and machine learning systems
Data integrity and 21 CFR Part 11 considerations
Using risk assessments to justify validation scope and effort
Change control and maintaining the validated state
Audit trail review and documentation strategies
Building an inspection-ready validation package
Defending validation decisions during regulatory inspections

Meet Your Instructor

Carolyn Troiano

Carolyn Troiano

Computer System Validation (CSV) & FDA Compliance Expert

Carolyn Troiano has more than 45 years of experience in computer system validation in the pharmaceutical, medical device, biotechnology, tobacco, and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, Computer System Validation (CSV), and large-scale IT system implementation projects. Carolyn participated in the FDA/Industry Partnership to develop 21 CFR Part 11, the FDA's Guidance for Electronic Records and Electronic Signatures. During her career she has provided consulting and training, including CSV, 21 CFR Part 11, Data Integrity, and many other related compliance topics of interest to the life science industries.

45+ Years CSV ExperienceFDA/Industry Partnership — 21 CFR Part 11Independent FDA Compliance ConsultantPharma, Medical Device & Biotech
Quantity
1

Single Recording

$250.00
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Certificate of completion

Event Details

Format

Recorded Webinar

Duration

3 hours/day (2-day course)

Certificate

Included

Access

Lifetime

Topics

CSVCSAGAMP 5Computer System ValidationData Integrity21 CFR Part 11Risk ManagementCloud ValidationAI ValidationInspection Readiness

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