آموزش اعتبارسنجی پیشرفته CSA و هوش مصنوعی: تسلط بر تحول CSV سال 2026 - آخرین آپدیت

سرفصل ها و درس ها

Introduction: The 2026 Transformation & Regulatory Strategy

• Welcome & The 2026 Roadmap

• The CSA Revolution (CSV vs. CSA)

• The Jan 2026 "Big Bang" (FDA & EMA Joint Principles)

• Data Integrity 2.0 (ALCOA++ for 2026)

• Module 1 Exam: The "Executive" Quiz

The CSA Revolution: Critical Thinking & Risk-Based Validation

• Selecting Your Project: Identifying High-Risk AI Use Cases.

• The CSA Risk Matrix: Categorizing AI Impact (GAMP 5 2nd Ed).

• Vendor Governance: Auditing Modella-style AI Foundation Models.

• The "Least Burdensome" Plan: Drafting the AI Validation Plan.

• Module 2 Exam: The CSA Revolution & Risk-Based AI Strategy

Advanced GAMP® 5 2nd Edition & Modern SDLC (Agile/SaaS)

• Cloud/SaaS Qualification. Validating what you don't own (AWS, Azure, and Google

• Critical Thinking over Checklists. Moving from Appendix M12 to real-world execut

• Module 3 Exam: Modern SDLC & GAMP® 5 Mastery

• Shared Responsibility

• "Critical Thinking" over "Checklist-Driven" validation

• "Unscripted Testing" for low-to-medium risk features

Validating AI & Machine Learning: Jan 2026 FDA/EMA Compliance

• Beyond the Script: Unscripted Testing for Non-Deterministic AI.

• Detecting Model Drift: Validating Continuous Learning Systems.

• Human-in-the-Loop: Validating the AI-User Interface.

• Bias & Explainability: Meeting Principle 10 (Plain Language).

Practical Mastery: End-to-End QMS Validation Lab

• The Interactive URS. Drafting User Requirements for a modern QMS.

• The Final Record of Assurance. Compiling Val Summary Report (VSR) in minutes

• Final Mastery Quiz: AI Validation & 2026 Standards

• Adversarial Testing"

• Record of Assurance

• Computer Software Assurance (CSA)

• Human-in-the-Loop

• Practice test for the AI CSV Gamechanger (2026 Edition)

• Context of Use (Regulatory Framework)