READY-TO-STREAM COURSE

AI for CAPA and Investigations

Where It Helps and Where It Can Get You in Trouble

Designed for professionals responsible for investigations, root cause evaluation, CAPA effectiveness, deviation management, or regulated quality system decision-making.

ABOUT THE COURSE

Investigation teams adopting AI-assisted workflows must now balance efficiency gains with the need for evidence-based conclusions, traceability, and accountable decision-making under review. This session structures practical controls for integrating AI into CAPA and investigation workflows while preserving analytical rigor, reviewer oversight, and process integrity.

The session begins by establishing regulatory expectations for investigations and CAPA activities within regulated environments. It then examines where AI can support efficiency, where its limitations create risk, and how organizations can implement verification, oversight, and review controls that maintain evidence-based conclusions and accountability throughout the investigation process.

Key Areas Covered

Appropriate and high-risk AI use within CAPA workflows
Maintaining evidence-based root cause and corrective action decisions
Risks introduced by AI-generated causal reasoning and summaries
Human oversight requirements for AI-assisted investigations
Verification and review controls for generated investigation content
Integrating AI into existing quality system procedures
Practical governance approaches for controlled AI-assisted investigations

Course Director

Charles H. Paul

Charles H. Paul has extensive experience working with regulated organizations on quality systems, technical documentation, operational controls, and structured process management. His background in performance-based training and regulatory consulting directly supports the practical integration of AI tools into investigation and CAPA environments where accountability, traceability, and evidence-based decision-making remain essential.

What Happens After You Reserve Your Seat

Your registration is managed by our events team to ensure a coordinated and seamless experience.

A confirmation email outlines onboarding details and next steps
Access credentials are shared in advance so you are prepared before the session
Handouts (where applicable) are provided ahead of time
The training is delivered live via Webex with interactive participation and Q&A
Certificates of completion are issued following the session
For live + recording access, post-session availability is provided through TalkFDA
Event support remains available for any access or logistics assistance

Access is provided in a structured and professionally supported format.

A confirmation email outlines onboarding and next steps
The complete session recording is delivered through TalkFDA
Access is granted shortly after purchase so you can begin without delay
Recording includes the full presentation and instructor-led discussion
Certificates of completion are issued upon course completion
Support remains available for any technical or access assistance

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