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AI for CAPA and Investigations:
Where It Helps and Where It Can Get You in Trouble

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** Registration to this course includes Trial access to TalkFDA Subscription and Members-only Community. Contact our Support for more details after the course completion.

This course helps organizations use AI within CAPA and investigation workflows without weakening evidence-based analysis, root cause determination, accountability, or regulatory credibility. This Course is designed for professionals responsible for investigations, root cause evaluation, CAPA effectiveness, deviation management, or regulated quality system decision-making.

  • 27 May 2026
  • Eastern Time (US/Canada): 11.00 AM
  • GMT: 3.00 PM
  • 60 Minutes
  • FDB1602
  • Charles H. Paul
  • Live Session + Post-live Continued Learning
  • Live Q&A Included
  • Presentation Handout & Templates
  • Assessment & Certification Included

REGISTRATION OPTIONS

Live session Plus Complimentary 30 Days Streaming access

$190  |  One participant (viewer)

$590  |  Team of up to 10 participants

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REGISTER FOR THE COURSE

US $290 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $290 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Charles H. Paul
  • Study time : 60 Minutes
  • Skill Level: Intermediate
  • Course ID: FDB1602
  • Assessment & Certification Included
  • Ask the Expert

Watch the Course Now  

Watch the Course Now   

 

Why take this course?

CAPA systems and investigation processes depend on evidence-based analysis, structured reasoning, and conclusions that can withstand regulatory scrutiny. As AI tools are introduced into investigation workflows, organizations are beginning to use them to summarize data, structure reports, and suggest potential causes. While this can improve efficiency, it also creates risk when generated logic begins replacing objective evaluation of evidence and disciplined root cause analysis.

This program focuses on how AI can be integrated into CAPA and investigation activities without weakening process integrity or accountability. The session examines where AI provides value, where its use introduces regulatory exposure, and how unsupported conclusions, prompt bias, or incomplete inputs can distort investigations. Emphasis is placed on maintaining human ownership of analysis, verifying AI-generated content, and ensuring conclusions remain attributable, evidence-based, and aligned with quality system expectations. Participants will also review practical controls for integrating AI into existing investigation and CAPA workflows without disrupting established procedures or approval practices.

  • Separate efficiency from investigative judgment:

    AI can organize data, summarize records, and improve documentation structure, but it cannot replace disciplined evaluation of evidence. This course helps teams distinguish acceptable support uses from higher-risk applications involving root cause determination, causal reasoning, and corrective action decisions. That distinction becomes critical when investigations are reviewed under regulatory scrutiny.

  • Strengthen control over AI-assisted investigations:

    Many organizations use AI informally without defined verification standards or reviewer accountability. This course helps establish practical controls for AI-generated outputs, reviewer responsibilities, and evidence verification while keeping investigations attributable to qualified personnel. The result is stronger alignment between investigation practice, CAPA workflows, and regulatory expectations for complete and defensible conclusions.

Key Areas Covered

  • Role of AI within CAPA and investigation activities
  • Regulatory expectations for evidence-based investigations and conclusions
  • Acceptable versus high-risk AI use cases in regulated workflows
  • Risks associated with AI-generated root cause analysis and causal reasoning
  • Bias, incomplete inputs, and limitations in AI-generated outputs
  • Verification, review, and accountability requirements for AI-assisted investigations
  • Integration of AI into existing CAPA procedures and approval workflows
  • Practical control approaches for maintaining investigation integrity and oversight

Who Must Attend

  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • CAPA Owners
  • Quality Investigators
  • Compliance Specialists
COURSE DIRECTOR

Charles H. Paul

Charles H. Paul has more than 30 years of experience in regulatory consulting, manufacturing, training, and technical documentation. His work designing solutions for complex documentation and training issues directly supports this webinar’s focus on investigation quality, structured analysis, reviewer accountability, and practical controls for AI-assisted CAPA and investigation workflows in regulated environments.

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Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

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Testimonials

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