Human Behavior Under FDA Scrutiny: How Words, Actions, and Reactions Shape Inspection Outcomes

This course enables participants to understand how individual and team behavior influences FDA inspection outcomes, and how investigator interactions, verbal responses, and day-to-day conduct are evaluated as evidence of system control.

Why This Training Matters

This course focuses on the human and behavioral dimension of FDA inspections, recognizing that inspections are not evaluated solely on documentation and procedures, but also on how people demonstrate knowledge, control, and accountability in real time. FDA investigators routinely assess credibility, consistency, and competence through interviews and informal interactions, often using employee responses as evidence of whether quality systems are truly understood and effectively implemented. This session explains how FDA interprets verbal responses, body language, and decision-making behavior as extensions of the quality system itself.

Agenda:

Lecture 1 - FDA’s View of Human Behavior as Evidence 

• Why FDA treats behavior as an extension of the quality system
• How inconsistent explanations signal lack of control
• What investigator notes capture beyond documents

Lecture 2 - How FDA Interprets Verbal Responses 

• The risk of speculation, opinion, and over-explanation
• “I think,” “usually,” and “we try to” as red-flag language
• How verbal responses are cross-checked against records

Lecture 3 - Role-Based Interaction Expectations

• What FDA expects from:
  • Operators and technicians
  • Supervisors and managers
  • Quality and Regulatory staff
• Why inconsistent answers across roles expand inspection scope

Lecture 4 - Training, Knowledge, and Competency Under Inspection 

• How FDA evaluates training effectiveness through interviews
• When training records fail to defend actual competency
• Investigator techniques for probing real understanding

Lecture 5 - Behavioral Triggers That Escalate Inspections 

• Defensive behavior and credibility loss
• Conflicting answers between departments
• Attempts to “fix” explanations in real time

Wrap-Up – Behavioral Control as Inspection Control 

• Aligning words, actions, and documentation
• Turning personnel interactions into inspection assets

This is Module 3 of Practitioner Course "FDA Inspection Readiness".

You can either sign up only for this Module here.

Or the entire course → Here

Who This Training Is Designed For

• Quality Assurance Departments
• Quality Control Departments
• Quality Systems Manager
• Regulatory Affairs Departments
• Compliance Departments
• Manufacturing Departments
• Operations Departments
• Production Departments
• Engineering Departments
• Validation Managers
• Process Development Leads
• Maintenance and Facilities Managers
• Calibration and Metrology Managers
• Laboratory Managers
• Analytical Development Leads
• Stability Program Managers
• Microbiology Supervisors
• Data Integrity Leads
• Training Managers
• Document Control Managers
• Supplier Quality Managers
• Complaint Handling Managers
• CAPA Program Owners
• Change Control Managers

Course Director: Charles H. Paul

Charles H. Paul is the President of CHP Consulting LLC – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 25 years and has published numerous white papers on varies subject from project management and technical writing to regulatory compliance in the life sciences.  The firm works with both domestic and international clients designing solutions for complex training and documentation issues within the life sciences.