Training Effectiveness Beyond "Read and Sign" - Building Competency - Based Programs That Reduce Errors and Stand Up to Inspections

  • Tuesday
  • March
  • 24
  • 2026
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes
Charles H. Paul Instructor:
Charles H. Paul
Webinar Id:
54707

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$149 Live
$299 Corporate Live
$199 Recorded
$399 Corporate Recorded
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Overview:

Training is one of the most frequently cited controls in regulated life sciences environments.

When deviations occur or procedures change, the default response is often to assign employees to "read and sign" updated documents or attend refresher sessions. While this approach satisfies documentation requirements, it rarely ensures that personnel can perform tasks correctly and consistently.

As a result, organizations may show 100 percent training completion yet continue to experience recurring errors, procedural noncompliance, and inspection findings. The problem is not a lack of training activity it is a lack of training effectiveness.

This webinar challenges the traditional attendance-based mindset and introduces a practical, performance-based approach to building real competency. Instead of measuring success by who completed a course or signed an SOP, effective training programs focus on what individuals can actually do.

Participants will learn how to identify critical tasks, define observable behaviors, and structure learning around hands-on practice and skill demonstration. By aligning training directly with job performance, organizations can ensure that employees are not just informed but capable.

A core concept explored in the session is the difference between passive knowledge transfer and active skill verification. Reading procedures or watching presentations may create awareness, but it does not guarantee correct execution under real-world conditions.

Performance-based models emphasize demonstration, observation, and feedback. Supervisors or trainers verify that individuals can complete tasks safely and accurately before they are considered qualified. This approach not only improves consistency but also reduces reliance on memory and interpretation, both of which are common sources of error.

The webinar also covers the use of qualification checklists and task sign-offs to formalize competency. Role-specific matrices and structured assessments provide clear evidence that personnel are prepared for their responsibilities. These tools create transparency and accountability while simplifying audits and inspections. Participants will learn how to design qualification systems that are practical, scalable, and aligned with risk.

Equally important is documenting training in a way that stands up to regulatory scrutiny. Inspectors increasingly expect to see proof of effectiveness, not just attendance records. Participants will explore how to maintain audit-ready training records that link roles, tasks, competencies, and performance outcomes. By integrating deviation and CAPA data into training programs, organizations can target skill gaps and measure improvement over time.

By the end of this session, attendees will understand how to move beyond "read and sign" practices and implement training systems that truly strengthen compliance, reduce errors, and improve operational performance.

Why should you Attend:
If your organization shows perfect training completion but still struggles with repeat deviations or inspection questions about competency, this webinar will help you close that gap. You'll learn how to replace passive, attendance-based training with performance-based methods that verify real skills, implement qualification checklists that prove capability, and create audit-ready records regulators trust.

Most importantly, you'll discover how to connect training directly to measurable improvements in quality and compliance, turning training from a paperwork exercise into a powerful tool for reducing errors and strengthening your quality system.

Areas Covered in the Session:

  • Welcome & Objectives (5 min)
    • Why "read and sign" training persists
    • The gap between training completion and real competency
    • Regulatory and operational risks of ineffective training
    • Session goals and expected outcomes
    • Learning objectives
  • Why Traditional Training Fails (7 min)
    • Attendance vs competence mindset
    • Passive learning methods
    • Information overload
    • Lack of hands-on practice
    • Training disconnected from real tasks
    • "Check-the-box" compliance culture
    • Recurring deviations despite completed training
    • Inspection findings tied to weak training systems
  • Regulatory Expectations for Training Effectiveness (8 min)
    • FDA/EMA expectations for personnel qualification
    • Evidence of competency vs attendance
    • Documentation requirements
    • Role-based qualification expectations
    • Inspection questions investigators ask
    • Common training-related 483 observations
    • Demonstrating control and oversight
  • Performance-Based Training Models (10 min)
    • Definition of performance-based training
    • Task analysis and job breakdown
    • Identifying critical skills and risks
    • Learning objectives tied to behaviors
    • Hands-on practice and simulations
    • Coaching and observation
    • Immediate feedback loops
    • Structured qualification pathways
    • Refresher strategies
    • Benefits for compliance and performance
  • Skill Demonstration vs Attendance (8 min)
    • Why completion records aren’t enough
    • Demonstration of competence in real tasks
    • Knowledge checks vs practical assessments
    • Observation-based evaluation
    • On-the-job validation
    • Supervisor sign-offs
    • Reducing reliance on memory
    • Examples of skill verification methods
  • Qualification Checklists & Task Sign-Offs (7 min)
    • Role-specific qualification matrices
    • Task-based competency lists
    • Step-by-step verification
    • Critical task identification
    • Risk-based prioritization
    • Standardized assessment criteria
    • Documentation of results
    • Maintaining qualification status
  • Audit-Proof Training Records (7 min)
    • What regulators expect to see
    • Linking roles to required training
    • Traceable records and version control
    • Qualification evidence
    • Training effectiveness measures
    • Electronic vs paper systems
    • Preparing for inspections
    • Common documentation pitfalls
  • Linking Training to Deviation Reduction (6 min)
    • Using deviation data to identify skill gaps
    • Trend analysis
    • Targeted retraining
    • Root cause integration
    • Measuring training impact
    • Continuous improvement cycle
    • KPIs and dashboards
    • Demonstrating measurable results
  • Practical Implementation Workflow (2–3 min)
    • Define tasks ? Analyze risk ? Train ? Demonstrate ? Qualify ? Monitor ? Improve
    • Ownership and accountability
    • Integration with QMS
  • Key Takeaways & Wrap-Up (2 min)
    • Competency beats attendance
    • Skills must be demonstrated
    • Documentation must prove capability
    • Metrics validate effectiveness
    • Training should prevent deviations
    • Strong systems improve inspection outcomes

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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