Metrics That Predict FDA Findings (Before FDA Does) - Using Leading Indicators to Detect Risk and Demonstrate Control

  • Thursday
  • March
  • 19
  • 2026
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes
Charles H. Paul Instructor:
Charles H. Paul
Webinar Id:
54705

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Overview:

Regulatory inspections rarely uncover problems that appear overnight. Most findings - whether related to deviations, CAPAs, training, or documentation - develop gradually over time. Backlogs grow, investigations age, training gaps widen, and recurring issues quietly signal that the quality system is under stress.

Yet many organizations fail to recognize these warning signs because they rely on traditional, backward-looking metrics that only describe what has already happened. By the time an issue is visible, it has already become a compliance risk. To stay inspection-ready, organizations must shift from reactive reporting to predictive measurement.

This webinar introduces a practical, data-driven approach to identifying risk before regulators do. Instead of focusing solely on lagging indicators such as total deviations closed or number of audits completed, participants will learn how to implement leading indicators that signal emerging weaknesses early. Leading indicators provide advance notice of system drift - revealing where controls are breaking down, resources are stretched, or processes are becoming unstable. By monitoring these signals, teams can intervene proactively and correct issues before they escalate into inspection findings or product impact.

The session explores which metrics truly matter in regulated environments. Participants will examine how to trend deviation recurrence, CAPA age, investigation cycle times, training effectiveness, and change control delays to uncover hidden patterns. These measures often reveal subtle but meaningful deterioration in system performance long before formal failures occur. Rather than waiting for major events, organizations can detect smaller, repeated signals that point to systemic risk.

A strong emphasis is placed on visual tools that make risk visible and actionable. Heat maps and dashboards transform raw data into clear, intuitive insights that help leaders prioritize resources and focus attention where it is needed most. Participants will learn how to design simple, effective dashboards that communicate trends quickly without overwhelming stakeholders. The goal is not more data, but better visibility and faster decisions.

The webinar also addresses how regulators interpret metrics during inspections. Agencies look for evidence that companies understand their processes and actively manage risk. Backlogs, aging records, repeat CAPAs, and inconsistent trends often suggest “loss of control” and trigger deeper scrutiny. By contrast, organizations that demonstrate proactive monitoring and timely corrective action show inspectors that their quality system is functioning as intended.

By the end of this session, attendees will have a clear framework for selecting meaningful indicators, establishing thresholds, and building a predictive metrics program that strengthens both compliance and operational performance. Instead of reacting to findings, teams will be equipped to prevent them.

Why should you Attend:
If you want to stop being surprised during inspections and start spotting problems before regulators do, this webinar will give you the tools to make that shift. You’ll learn how to move beyond basic counts and reports and instead use leading indicators, smart trending, and visual dashboards to detect early-warning signals that reveal hidden risk.

By understanding what metrics truly predict compliance issues - and what regulators interpret as loss of control - you’ll be able to prioritize resources, reduce backlogs, and demonstrate a proactive, well-managed quality system. You’ll leave with practical techniques you can apply immediately to strengthen oversight, improve decision making, and prevent findings before they happen

Areas Covered in the Session:

  • Welcome & Objectives (5 min)
    • Why inspections rarely produce “surprises”
    • Findings are usually predictable through internal signals
    • Moving from reactive to predictive compliance
    • Session goals and expected outcomes
    • Learning objectives
  • Why Traditional Metrics Fail (6 min)
    • Overreliance on lagging indicators
    • Counting events instead of managing risk
    • “Closed = good” mindset
    • Metrics that look good but hide problems
    • Consequences during inspections
    • Need for predictive measures
  • Leading vs Lagging Indicators Explained (8 min)
    • Definitions and differences
    • Examples of lagging indicators
    • Examples of leading indicators
    • How leading indicators signal risk earlier
    • Balancing both types
    • Building a proactive measurement strategy
  • Trending What Matters: Core Quality Signals (12 min)
    • Deviation volume and recurrence
    • Aging deviations and backlog growth
    • CAPA age and effectiveness rates
    • Investigation cycle time
    • Training completion vs competency gaps
    • Repeat training failures
    • Change control delays
    • Supplier and audit trends
    • Identifying patterns before escalation
    • Practical trending techniques
  • Early-Warning Signals of System Drift (8 min)
    • Increasing “minor” deviations
    • Temporary fixes and extensions
    • Late investigations
    • Workarounds and undocumented practices
    • Missed review timelines
    • Staff workload imbalance
    • Inconsistent data integrity practices
    • Inspection red flags regulators recognize
  • Heat Maps & Dashboards for Visibility (8 min)
    • Visualizing risk across departments
    • Risk scoring approaches
    • Building heat maps
    • Simple dashboard design principles
    • Prioritizing attention
    • Executive-level summaries
    • Avoiding overcomplicated reports
    • Real-time vs monthly views
  • What Regulators Interpret as “Loss of Control” (7 min)
    • Backlogs and aging records
    • Repeated CAPAs
    • Incomplete investigations
    • Ineffective corrective actions
    • Missing trend analysis
    • Data inconsistencies
    • Poor management review
    • Documentation without evidence of action
  • Building a Predictive Metrics Program (4 min)
    • Selecting meaningful KPIs
    • Setting thresholds and triggers
    • Ownership and accountability
    • Review cadence
    • Escalation pathways
    • Continuous improvement loop
  • Key Takeaways & Wrap-Up (2 min)
    • Measure risk, not just activity
    • Leading indicators prevent surprises
    • Visual dashboards drive action
    • Early detection reduces findings
    • Metrics demonstrate control to regulators
    • Proactive systems improve performance

Who Will Benefit:
  • Quality Assurance (QA)
  • Quality Control (QC)
  • Regulatory Affairs
  • Compliance and Governance
  • Internal Audit
  • Manufacturing Operations
  • Production Management
  • Validation and Engineering
  • Training and Learning & Development
  • Document Control and Technical Writing
  • CAPA and Investigation Teams
  • Risk Management
  • Supplier Quality Management
  • Laboratory Operations
  • Site and Plant Leadership
  • Continuous Improvement / Operational Excellence
  • Data Integrity and CSV/CSA Teams
  • Clinical Operations (GCP environments)
  • Contract Manufacturing Oversight
  • Executive Quality and Compliance Leadership


Speaker Profile
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.

He has dedicated his entire professional career explaining the benefits of performance-based training


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