AI Governance Roadmap for QA Leaders: Controls, SOPs, Validation Evidence, and Inspection Readiness
Establish practical requirements for controlling AI use across GMP quality systems, validation activities, documentation, supplier management, lifecycle changes, and inspection preparation.
AI-supported GMP activities require defined approval and accountability pathways.
When AI becomes part of GMP decision-making, two focused days provide a structured path for establishing governance before adoption expands across operations.
The program organizes governance activities into practical quality system components covering oversight, documentation, validation evidence, supplier controls, and inspection preparation activities suitable for regulated implementation.
The seminar progresses in a deliberate sequence across two days. The first day establishes governance foundations, organizational responsibilities, and quality system integration. The second day extends those foundations into validation evidence, lifecycle oversight, supplier management, and inspection preparation, creating a practical implementation path rather than isolated topics.
Governance Foundations and Quality Systems Integration
- MODULE 1: Understanding AI Risk in Regulated Environments
- MODULE 2: Building an AI Governance Framework
- MODULE 3: Policies, Procedures, and SOP Development
- MODULE 4: Risk Management and Data Governance
Validation, Inspection Readiness, and Sustainable Oversight
- MODULE 5: Validation Strategy and Evidence Requirements
- MODULE 6: Lifecycle Management and Change Control
- MODULE 7: Supplier Oversight and Third-Party AI Systems
- MODULE 8: Inspection Readiness and Audit Preparation
Designed for professionals responsible for integrating, governing, validating, reviewing, or overseeing AI use within regulated quality and operational environments.
Charles H. Paul
Charles H. Paul brings more than 30 years of experience implementing GMP quality systems, computerized system validation, documentation controls, data integrity programs, risk management processes, and inspection-readiness activities. His work across pharmaceutical, biotechnology, medical device, and advanced therapy organizations directly supports the procedural, validation, governance, and operational requirements addressed throughout this program.
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Customized training is also available through TalkFDA Elite Training Labs.
This topic can also be delivered as a customized session for organizations seeking structured, implementation-focused training aligned with their internal processes and quality systems.
TalkFDA Elite Training Labs