Live Webinar – Back on Popular Demand
Inspection Readiness 2026
Defending Your Use of AI to FDA and Auditors
- June 05, 2026
- 11 AM Eastern Time US
- 3 PM GMT
- 60 Minutes
EXCLUSIVE OFFER: Get your team to attend for just $ 290. Post-Live Q&A and Complimentary Course Replay Included. Individual registration available too.
Designed for professionals responsible for ensuring processes, documentation, and personnel explanations remain consistent when AI influences quality system activities.
ABOUT THE COURSE
When preparing for inspection, the question is how AI-supported activities are explained, verified, and aligned with documented processes under direct regulatory review. This session structures how AI use is controlled, documented, and communicated, aligning real execution with procedures, personnel responses, and inspection expectations.
The session follows how inspections unfold, then connects observed process gaps to AI involvement. It focuses on aligning procedures with execution, defining control boundaries, and preparing personnel and documentation to withstand detailed questioning, ensuring consistency between what is done, recorded, and explained during inspection.
Key Areas Covered
- Identifying where AI use becomes visible during inspections and audits
- Recognizing trigger points that prompt deeper regulatory scrutiny
- Aligning AI use with SOPs and documented workflows
- Establishing accountability for AI-assisted outputs and decisions
- Preparing personnel to provide consistent process explanations
- Ensuring documentation reflects actual execution and verification
- Conducting internal assessments to identify control and alignment gaps
Charles H. Paul
Charles H. Paul brings extensive experience in regulatory consulting, training systems, and documentation practices, directly relevant to inspection readiness. His work focuses on aligning procedures, training, and execution, enabling organizations to clearly explain and support how processes operate, including where AI influences outcomes within regulated quality systems.
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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