Inspection Readiness: Defending Your Use of AI to FDA and Auditors
Description
This webinar provides a detailed and operationally focused approach to preparing organizations to defend their use of artificial intelligence during regulatory inspections and audits by aligning AI use with established quality system expectations and ensuring that it can be clearly explained, supported, and justified under scrutiny.
The session begins by examining how inspections actually unfold in practice, starting with high-level evaluation of the quality system and progressing into detailed process walkthroughs, document reviews, and personnel interviews. Participants will see how inconsistencies between procedures, documentation, and explanations often reveal the presence of AI even when it is not explicitly disclosed. AI use typically becomes visible through gaps in traceability, differences in how processes are described, and outputs that appear structured but lack clear evidence of how they were developed. The webinar then identifies specific trigger points where AI involvement is most likely to surface, including SOP development and revision processes, CAPA and deviation investigations, training material creation, and data summarization activities. Participants will learn how these trigger points lead inspectors to probe deeper into process control, accuracy, and accountability.
WHY YOU SHOULD ATTEND
Most organizations do not believe they are using artificial intelligence in a way that impacts regulatory compliance, but in practice AI is already influencing critical quality system activities without formal recognition or control. SOP authors use AI to draft content, investigators use it to summarize deviation data, and training teams use it to develop materials, often without defined procedures, consistent application, or documented oversight.
Inspectors are not going to ask whether AI is being used; they are going to evaluate how processes are performed, how accuracy is ensured, and who is responsible for the outcome. When AI has influenced a process and its use is not clearly defined, consistently applied, and properly verified, the process appears uncontrolled. This leads to loss of confidence in documentation, questions about the validity of investigations, and increased scrutiny of the overall quality system.
The risk is compounded by the fact that many organizations believe they have control, but that control is often informal, inconsistently applied, or not aligned with actual practice. Different personnel may describe the same process in different ways, documentation may not reflect how work is truly performed, and accountability for AI-assisted outputs may be unclear. During an inspection, these inconsistencies are quickly identified and can trigger deeper investigation into process control.
AREAS COVERED
- How inspections are conducted and how auditors evaluate AI-influenced processes
- Where AI use becomes visible during document review and personnel interviews
- Trigger points that lead to deeper regulatory scrutiny
- Defining a defensible position for AI use within quality systems
- Aligning AI use with SOPs and documented procedures
- Preparing personnel to provide consistent and accurate explanations
- Ensuring documentation supports actual process execution
- Common failure scenarios and their root causes
- Internal assessment methods to identify gaps
- Practical steps to improve inspection readiness and defensibility
WHO SHOULD ATTEND
- Quality Assurance
- Regulatory Affairs
- Compliance
- Quality System Owners
- CAPA and Investigation Leaders
- Validation and CSA Specialists
- Documentation and Technical Writing Leads
- Training and Learning & Development Managers
- Inspection Readiness Teams
TOPIC BACKGROUND
Artificial intelligence is now being used across quality systems in regulated environments—often in ways that are not formally defined or consistently controlled. Tools such as ChatGPT are being applied to draft SOPs, summarize deviations, support CAPA investigations, generate training content, and assist with regulatory documentation. While these applications can improve efficiency, they introduce a critical shift: the method by which information is generated and decisions are supported is changing, but regulatory expectations are not.Regulatory agencies, including the U.S. Food and Drug Administration, do not evaluate tools in isolation. They evaluate whether:
- Processes are defined and consistently executed
- Outputs are accurate and appropriate
- Responsibilities are clearly assigned
- Decisions are evidence-based and defensible
If AI is used within a process, it becomes part of that process. If it is not defined, controlled, and supported by documentation, it effectively exists outside the quality system—even if it is widely used. This creates a disconnect between how work is actually performed and how it is represented during inspection. This webinar focuses on closing that gap—ensuring that AI use is not only controlled, but explainable, consistent, and defensible under direct regulatory scrutiny.
Course Director: Charles Paul
Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, manufacturing, training, and technical documentation consulting firm - celebrating its twentieth year in business in 2017. He has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues. He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.
