A practical, two-day framework for applying CSV, CSA, GAMP® 5 principles, and quality risk management to modern GxP systems — cloud, SaaS, configurable, and AI-enabled — with the emphasis on inspection readiness and regulatory-defensible decisions, not excessive documentation.
Includes live access & recording
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.
Attendees leave able to apply risk-based thinking to reduce unnecessary validation activities while maintaining compliance, to make and defend validation decisions during inspections and audits, and to validate cloud, SaaS, configurable, and AI-enabled systems with confidence.
Hands-on exercises demonstrate how to apply risk-based validation concepts to real-world GxP systems, and participants leave with practical tools, templates, and decision-making frameworks that can be applied immediately within their organization.
Ten practical outcomes spanning FDA's CSA approach, risk-based validation, modern platforms, and inspection-ready decision-making.
Understand what FDA's CSA approach means in practice and how it differs from traditional CSV.
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.
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 applying risk-based validation concepts to real-world GxP systems.
Leave with practical tools, templates, and decision-making frameworks that can be immediately applied.
Four focus areas that turn CSA principles into defensible, inspection-ready validation practice.
Understand intended use and fitness for purpose, and apply critical thinking to decide where validation effort actually belongs — instead of documenting everything equally.
Use risk assessments to justify validation scope and effort, determine system criticality and complexity, and focus testing on functions that affect patient safety, product quality, and data integrity.
Apply validation approaches for SaaS, cloud, configurable, AI, and machine-learning systems, and leverage supplier assessments and vendor documentation appropriately.
Build an inspection-ready validation package, maintain the validated state through change control, and defend validation decisions during FDA, EMA, MHRA, and customer scrutiny.
Day 1 builds the foundations of modern CSV and CSA; Day 2 turns them into defensible validation decisions in practice.
Everyone responsible for maintaining compliant and validated cloud-based and AI-enabled systems across the life sciences.
Quality Assurance Departments
Validation & CSV Practitioners
IT & Digital Transformation Leaders
System Owners
Data Integrity Specialists
Compliance Departments
AI Governance Teams
Regulatory Affairs Departments
This course 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.
FDA's Computer Software Assurance (CSA) guidance reframes decades of Computer System Validation practice around critical thinking and risk. Rather than producing large volumes of uniform test evidence, organizations are expected to identify a system's intended use, assess where failure could affect patient safety, product quality, or data integrity, and concentrate assurance activity there — using unscripted, exploratory, and scripted testing in proportion to risk.
Modern GxP systems make this shift unavoidable. Cloud and SaaS platforms are maintained by suppliers, configurable systems change frequently, and AI-enabled and machine-learning components behave in ways traditional test scripts were never designed to cover. Regulators from FDA, EMA, and MHRA — along with customers and partners — expect validation decisions that are risk-based, scientifically justified, and defensible on inspection.
This two-day course connects CSV, CSA, GAMP® 5 and its 2nd Edition, quality risk management, data integrity, and 21 CFR Part 11 into a single working framework, and uses hands-on exercises and real-world case studies so participants leave with tools, templates, and decision-making frameworks they can apply immediately.
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.
Join Carolyn Troiano for this two-day course on risk-based CSV/CSA for modern GxP systems and making defensible validation decisions in practice.