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2-Day Virtual Seminar - FDA Inspection Readiness in the AI Era (ONLINE EVENT: November 16-17, 2026)- Product Image
2-Day Virtual Seminar - FDA Inspection Readiness in the AI Era (ONLINE EVENT: November 16-17, 2026)- Product Image
New

2-Day Virtual Seminar - FDA Inspection Readiness in the AI Era (ONLINE EVENT: November 16-17, 2026)

  • Training

  • 2 Days
  • Nov 16th 12:30 - Nov 17th 05:00 EST
  • World Compliance Seminar
  • ID: 6290522
Description Jump to:
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 Content

Day 1 - FDA AI-Driven Inspection Risk & Compliance Expectations
Session 1: The Future of FDA Inspections in 2026
  • FDA’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 - Practical Strategies for Inspection Success & Regulatory Defense
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

Speaker

Kelly Thomas

Who Should Attend

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

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