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Inspection Readiness: Defending Your Use of AI to FDA and Auditors

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This course enables organizations to convert informal AI use into controlled, clearly defined processes that can be consistently explained, verified, and justified during inspections, reducing exposure created by undocumented practices and inconsistent personnel responses. This Course is designed for professionals responsible for result assessment, investigation oversight, and quality decisions that must withstand regulatory review.

  • Charles H. Paul
  • 60 Minutes
  • FDB1603
  • Presentation Handout & Templates
  • Assessment & Certification Included
  • Ask the Expert

REGISTRATION OPTIONS

30 Days Streaming access

$190  |  One participant (viewer)

$590  |  Team of up to 10 participants

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Why take this course?

Artificial intelligence is increasingly embedded in quality system activities, yet its use is often informal, inconsistently applied, and not clearly reflected in procedures or documentation. During inspections, regulators do not evaluate tools directly; they assess how processes are executed, how outputs are verified, and whether accountability is clearly established. When AI influences activities such as SOP development, CAPA investigations, or training content without defined controls, gaps in traceability and inconsistent explanations quickly expose weaknesses in process control.

This session focuses on how organizations can prepare to defend AI use under inspection conditions by aligning it with established quality system expectations. It examines how inspections unfold in practice, where AI involvement becomes visible, and how inconsistencies between documentation and execution trigger deeper scrutiny. Emphasis is placed on defining controlled use, maintaining alignment between procedures and real-world execution, preparing personnel to respond consistently, and ensuring documentation provides clear evidence of how outputs were generated, reviewed, and justified.

  • Define and demonstrate control over AI use:

    Organizations often rely on AI without formally integrating it into their quality systems. This course builds the ability to define how AI is used within procedures, establish boundaries for its application, and ensure outputs are reviewed at an appropriate level of risk. That clarity supports consistent execution and reduces the likelihood of inspection concerns around uncontrolled processes.

  • Prepare personnel and documentation for inspection scrutiny:

    Inspection outcomes are influenced by how consistently processes are explained and how well documentation reflects actual execution. This course strengthens how teams align responses with procedures, ensure records demonstrate traceability and verification, and avoid inconsistencies that signal gaps in control. This becomes critical when inspectors evaluate accountability, accuracy, and decision-making under real conditions.

Key Areas Covered

  • How inspections unfold and how AI-influenced processes are evaluated
  • Where AI use becomes visible during document review and personnel interviews
  • Trigger points that lead to deeper regulatory scrutiny
  • Defining controlled use and accountability within quality systems
  • Aligning procedures with actual execution of AI-supported activities
  • Preparing personnel for consistent, accurate inspection responses
  • Documentation practices that demonstrate traceability and verification
  • Common failure scenarios and internal assessment approaches

Who Must Attend

  • QA/QC Departments
  • Quality System Owners
  • CAPA and Investigation Leaders
  • Regulatory Affairs Departments
  • Compliance Professionals
  • Validation Departments
COURSE DIRECTOR

Charles H. Paul

Charles H. Paul has over 30 years of experience in regulatory consulting, training development, and documentation practices across FDA-regulated industries. His work in designing training systems and addressing complex documentation challenges directly supports the need to align AI-supported processes with controlled procedures and consistent execution under inspection conditions.

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Testimonials

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“Session was easy to follow even for non-core team members. That helped.”
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- Director, Operations

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