Risk-Based CSV/CSA for Modern GxP Systems:
Making Defensible Validation Decisions in Practice
Register Now- Risk-based determination of validation scope, testing depth, and evidence
- CSV and CSA application across cloud, SaaS, configurable, and AI-enabled systems
- Intended use, system criticality, and GxP risk assessment
- Supplier evidence evaluation and allocation of validation responsibilities
- 21 CFR Part 11, data integrity, and lifecycle control considerations
- Inspection-ready validation rationale, documentation, and decision justification
Building the Risk-Based Validation Foundation
- Moving from documentation-heavy CSV to practical CSA
- Deciding what requires validation and how much
- Using intended use to establish validation boundaries
- Determining criticality, complexity, and GxP system risk
- Applying GAMP 5 principles without unnecessary validation effort
- Setting requirements, traceability, testing, and evidence expectations
- Using supplier documentation without surrendering validation responsibility
- Validating SaaS, cloud, and configurable GxP systems
Making and Supporting Validation Decisions in Practice
- Choosing scripted, unscripted, and exploratory testing by risk
- Applying CSA within Agile, DevOps, and continuous deployment
- Setting validation approaches for AI-enabled and machine learning systems
- Connecting data integrity with 21 CFR Part 11 controls
- Using risk assessments to justify validation scope and effort
- Managing changes without losing the validated state
- Building inspection-ready evidence around key validation decisions
- Working through real-world validation decisions and inspection scenarios
Two focused days examine where validation effort belongs, what evidence is sufficient, and how risk should shape decisions across modern GxP systems.
The seminar builds from core CSV and CSA principles into applied validation choices for cloud, SaaS, configurable, AI-enabled, and continuously changing systems.
The first day establishes the basis for deciding validation scope, rigor, testing, and evidence using intended use, system risk, and supplier information. The second day carries those decisions into modern development environments, testing approaches, data integrity, lifecycle controls, and practical inspection situations where validation rationale must be clearly supported.
Carolyn Troiano brings more than 45 years of computerized system validation experience across FDA-regulated industries, including extensive consulting and training on CSV, 21 CFR Part 11, and data integrity. Her participation in the FDA/Industry Partnership supporting Part 11 development and experience with large-scale system implementations provide the practical depth required for an applied two-day validation seminar.