The Leader in Quality Life Science Training
READY-TO-STREAM COURSE
Inspection Readiness
Defending Your Use of AI to FDA and Auditors
A practical session on preparing AI-influenced quality system activities for inspection questioning, document review, personnel interviews, and auditor scrutiny.
- Charles H. Paul
- 60 Minutes
- Instant Streaming Available
- Assessment & Certification
- 30-Day Continued Learning
COURSE OVERVIEW & STRUCTURE
AI use is often surfacing during quality system inspections.
Quality teams need clear positions on where AI is used, how outputs are reviewed, and who remains accountable during inspection questioning. This session structures AI use review, procedure alignment, documentation evidence, personnel preparation, and internal readiness assessment for regulated quality systems.
The session follows the inspection path from quality system review to process walkthroughs, records, and personnel interviews. It examines where AI involvement becomes visible, how procedures and actual practice should align, and what evidence is needed to support controlled use during audit questioning.
WHAT YOU’LL LEARN
Justifying AI use under inspection
- How auditors identify AI-influenced processes
- AI trigger points in SOPs, CAPA, training, and summaries
- Aligning AI use with documented procedures
- Verifying AI-assisted outputs before approval
- Preparing personnel for consistent inspection responses
- Ensuring records reflect actual process execution
- Finding gaps through internal AI use assessments
- Correcting informal or inconsistent AI practices
WHO SHOULD ATTEND
Designed for professionals responsible for controlled AI use, inspection responses, process documentation, or quality system execution.
Quality Assurance
Regulatory Affairs
Technical Writing
Validation
Compliance
Training and Learning
CAPA Investigators
Inspection Readiness
FACULTY
Charles H. Paul
Charles H. Paul brings 30 years of regulatory, manufacturing, training, and technical documentation consulting experience. His work with regulated documentation systems, training development, and quality process communication makes him well suited to address how AI use should be explained, documented, reviewed, and supported during FDA inspections and auditor questioning.
After you register your seat, our team organizes everything for you; from access to certification – “from one place”.
- You receive a confirmation and your course appears instantly in your TalkFDA dashboard.
- Your course page becomes your central hub where you can join the session, access materials, and manage your learning.
- At the scheduled time, simply click Join Session and you’ll be connected to the live Webex session with the instructor.
- After the session, the playback becomes available on the same course page so you can revisit important sections.
- Complete the course and your certificate is unlocked automatically in your learning history.
For Teams Seeking Deeper Implementation Support
Customized training is also available through
TalkFDA Elite Training Labs.
This topic can also be delivered as a customized session through TalkFDA Elite Training Labs for organizations seeking structured, implementation-focused training aligned with their internal processes and quality systems.
Elite Training Labs sessions are tailored for teams and delivered in formats designed to support application, discussion, and practical integration beyond the live webinar format.
Inspection Readiness
Defending Your Use of AI to FDA and Auditors
- Instant Ready-to-Stream Access
- 60 Minutes Learning Time
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