2 Day Virtual Seminar

FDA Inspection Readiness in the AI Era 2026

Preparing for AI-Driven Regulatory Targeting & Perpetual GMP Compliance

Date July 22-23, 2026
US Time 12:00 PM - 05:00 PM ET
CET Time 06:00 PM - 11:00 PM CET
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You get 5 log-in for the live 2 Day virtual seminar for all the participant, presentation materials, Certificate and the opportunity to ask questions by phone and email.

  • Up to 5 participant log-ins
  • Live 2-day virtual seminar
  • Presentation materials
  • Certificate included
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You'll have 12 month single user access to log-in for an archived recording of the entire 2 Day virtual seminar, including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session.

  • 12-month single-user access
  • Archived seminar recording
  • Presentation materials
  • Audio recording and transcript
Buy On-Demand for $1,198

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Course Description

FDA Inspection Readiness in the AI Era 2026

Build continuous inspection readiness for AI-driven regulatory targeting, GMP compliance, data integrity, CAPA effectiveness, and quality culture.

Course Description

As the FDA increasingly adopts AI-driven risk analysis and advanced compliance monitoring tools to identify high-risk facilities, pharmaceutical and biotech companies must transition from periodic inspection preparation to continuous inspection readiness.

This intensive 2-day virtual seminar provides practical strategies to help organizations prepare for evolving FDA inspection models, data-driven enforcement trends, AI-assisted risk targeting, and increasing regulatory expectations surrounding GMP compliance, data integrity, CAPA effectiveness, and quality culture.

Participants will learn how to strengthen inspection readiness programs, reduce compliance vulnerabilities, and build sustainable systems that support perpetual regulatory readiness.

Course Inclusions

  • ๐Ÿ’ป Get Free FDA Inspection Readiness Checklist 2026
  • ๐Ÿงช Real Inspection Examples & Case Studies
  • ๐Ÿ“ Mock FDA Inspection Exercises
  • ๐ŸŽค Interactive Q&A
  • ๐ŸŽ“ 10 hours of Continuing Education with Certificate

Key Learning Benefits

  • Understand how FDA AI-driven targeting may impact inspections
  • Improve continuous inspection readiness strategies
  • Reduce compliance risks and repeat observations
  • Strengthen CAPA and investigation effectiveness
  • Improve data integrity and documentation practices
  • Build a stronger GMP quality culture
  • Prepare teams for modern FDA inspection expectations

Faculty: Kelly Thomas

Head of Quality Assurance, USA | 25+ years of experience

Kelly Thomas is a seasoned Quality Assurance, Quality Control, and Regulatory Compliance leader with 25+ years of experience across API, biologics, medical devices, and combination products. She brings extensive expertise in aseptic and terminally sterilized manufacturing, along with all major dosage forms.

Kelly has a proven track record of leading facility start-ups and successfully managing global regulatory inspections, including FDA and international agencies. She is known for building strong quality systems, supplier management programs, and audit readiness frameworks.

Brings practical, inspection-ready insights to help you strengthen compliance and avoid costly mistakes.

Who Should Attend?

  • Quality Assurance Professionals
  • GMP Compliance Teams
  • Manufacturing & Operations Leaders
  • Validation & CSV Professionals
  • Regulatory Affairs Teams

Also Recommended For

  • CAPA & Investigation Specialists
  • Data Integrity & IT Compliance Teams
  • Plant Managers & Site Leadership
  • Internal Auditors & Inspection Readiness Teams
Training Agenda

2-Day FDA Inspection Readiness Agenda

A compact, easy-to-scan agenda covering AI-driven inspection risk, perpetual GMP readiness, regulatory defense, and mock inspection planning.

Day 1 โ€” FDA AI-Driven Inspection Risk & Compliance Expectations

Duration: 5 Hours
Session 1: The Future of FDA Inspections in 2026
  • FDAโ€™s evolving risk-based inspection strategy
  • How AI and data analytics are influencing inspection prioritization
  • Understanding high-risk facility indicators
  • FDA enforcement trends and warning letter analysis
  • Impact of repeat observations and compliance history
Session 2: AI-Driven Risk Signals & Data Integrity Red Flags
  • Data integrity risks attracting regulatory attention
  • Electronic records and metadata review trends
  • CAPA effectiveness and recurring deviation analysis
  • Quality metrics and complaint trending
  • Supplier and vendor oversight risks
Session 3: Building a State of Perpetual Inspection Readiness
  • Moving beyond inspection preparation
  • Creating sustainable inspection-ready systems
  • Documentation and record readiness strategies
  • Internal audit best practices
  • Inspection readiness governance models
Session 4: Human Error, Quality Culture & Operational Risk
  • Human error as a leading inspection risk factor
  • Building a proactive GMP quality culture
  • Training effectiveness and competency management
  • Supervisory oversight and accountability
  • Reducing repeat failures and deviations

Day 2 โ€” Practical Strategies for Inspection Success & Regulatory Defense

Duration: 5 Hours
Session 5: Managing FDA Inspections & Investigator Interactions
  • Preparing teams for unannounced inspections
  • FDA investigator interview management
  • Managing document requests and inspection flow
  • Inspection communication best practices
  • Remote and hybrid inspection expectations
Session 6: CAPA, Investigations & Compliance Remediation
  • FDA expectations for investigations and CAPAs
  • Root cause analysis best practices
  • Avoiding weak or ineffective corrective actions
  • Building sustainable remediation plans
  • Inspection response documentation
Session 7: AI, CSA, Computer Systems & Compliance Risk
  • FDA expectations for computerized systems
  • CSA vs traditional CSV approaches
  • AI and automated system oversight considerations
  • Part 11 and electronic data governance
  • Cloud systems and vendor compliance risks
Session 8: Mock Inspection Workshop & Action Planning
  • Simulated FDA inspection scenarios
  • Common inspection mistakes and red flags
  • Building facility-specific readiness plans
  • Developing continuous compliance improvement programs
  • Final Q&A and implementation roadmap