CSV/CSA Masterclass for Modern GxP Systems - Defensible Validation Decisions Using Risk-Based Thinking
Description
This course shows how to make validation decisions FDA can follow, defend, and trust. It connects CSV fundamentals with CSA risk thinking to create clear validation rationales, right-sized testing, and inspection-ready documentation across modern GxP systems.
Modules:
Module 1: CSV/CSA Foundations: Defensible Validation Decisions Using Risk-Based Thinking (February 24, 2026)
Module 2: Risk-Based CSV/CSA Testing: Making Smart Testing Decisions FDA Can Defend (February 25, 2026)
Module 3: CSV/CSA for Cloud & SaaS Systems: Using Supplier Evidence Without Increasing Risk (February 26, 2026)
Module 4: CSV/CSA Inspection Readiness: Presenting Risk-Based Validation Decisions with Confidence (February 27, 2026)
Why This Training MattersValidation expectations have shifted, but confusion inside organizations remains high. The CSV/CSA Masterclass for Modern GxP Systems addresses the growing gap between traditional CSV habits and FDA’s emphasis on risk-based decision-making under Computer Software Assurance. Teams struggle to interpret intended use, automation impact, and system risk consistently, often resulting in either over-validation or fragile assurance that collapses under inspection pressure.Across pharma, biotech, and medical devices, validation decisions now span on-prem, cloud, and hybrid systems. Poorly justified testing strategies, excessive documentation, and weak validation rationales routinely surface during inspections. FDA scrutiny increasingly focuses on how decisions were made — not how many documents exist. The CSV/CSA Masterclass for Modern GxP Systems provides a grounded framework to align CSV fundamentals with CSA principles, without abandoning defensibility.By anchoring validation in risk logic, data integrity, and Part 11 compliance, organizations gain clarity and consistency. The CSV/CSA Masterclass for Modern GxP Systems helps teams explain their decisions confidently, reduce inspection exposure, and maintain control as systems, vendors, and automation continue to evolve. | Who This Training Is Designed For
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Module Details
| MODULE 1: CSV/CSA Foundations: Defensible Validation Decisions Using Risk-Based Thinking February 24, 2026 | 3 Hours This course clarifies how to build validation rationales FDA can follow, combining CSV discipline with CSA risk thinking to support defensible decisions without unnecessary over-validation. AGENDA:
| MODULE 2: Risk-Based CSV/CSA Testing: Making Smart Testing Decisions FDA Can Defend February 25, 2026 | 3 Hours This course sharpens testing judgment by tying CSA testing categories directly to FDA expectations, helping teams defend test depth, evidence quality, and validation ownership with confidence. AGENDA:
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| MODULE 3: CSV/CSA for Cloud & SaaS Systems: Using Supplier Evidence Without Increasing Risk February 26, 2026 | 3 Hours This course explains how to use supplier evidence intelligently, maintain validation ownership, and control cloud systems without inflating risk or inspection exposure. AGENDA:
| MODULE 4: CSV/CSA Inspection Readiness: Presenting Risk-Based Validation Decisions with Confidence February 27, 2026 | 3 Hours This course clarifies how to build validation rationales FDA can follow, combining CSV discipline with CSA risk thinking to support defensible decisions without unnecessary over-validation. AGENDA:
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