Inside the FDA Inspection: Managing Interviews, Requests, and FDA 483 Risk in Real Time

This course teaches participants how to manage FDA investigator interactions, document requests, interviews, and observations in a manner consistent with FDA inspection authority, procedures, and enforcement practices.

Why This Training Matters

This course shifts the focus to inspection execution and response, addressing what happens once an inspection begins and how risk must be actively managed in real time. Participants learn how FDA investigators structure interviews, request documents, and test the alignment between written procedures and observed practices. The session provides practical guidance on responding to investigator questions accurately and professionally, managing document requests without creating contradictions, and recognizing when an observation may be forming. The goal is not to script responses, but to equip organizations with the situational awareness needed to avoid common behaviors that unintentionally expand inspection scope or escalate regulatory risk.

Agenda:

Lecture 1 - The Opening of an FDA Inspection 

• FDA authority upon arrival (FDA Form 482)
• Establishing inspection logistics and communication protocols
• Why early missteps expand inspection scope

Lecture 2 - FDA Interview Strategy and Question Design 

• How FDA uses interviews to test system consistency
• Recognizing questions designed to:
  • Verify procedural adherence
  • Expose undocumented practices
  • Assess training effectiveness
• Coaching staff to respond accurately without creating risk

Lecture 3 - Document Requests and FDA Evidence Building 

• How FDA evaluates document flow and response timing
• Managing document retrieval without contradicting systems
• Avoiding the “document avalanche” that exposes weaknesses

Key FDA Forms

• FDA Form 482
• FDA Form 483 (contextual lead-up)

Lecture 4 - Managing Potential Observations During the Inspection 

• How FDA develops inspection observations
• What corrections are acceptable during an inspection
• Professional disagreement vs. argumentative behavior

Lecture 5 - Understanding FDA 483 Observations 

• What a 483 represents—and what it does not
• How FDA determines observation wording and severity
• Relationship between 483s, Warning Letters, and enforcement escalation

Key FDA Guidance

• FDA Guidance on FDA 483 Responses
• Regulatory Procedures Manual (RPM)

Lecture 6 - Post-Inspection FDA Response Strategy 

• Writing effective FDA 483 responses
• Demonstrating control without over-committing
• Aligning CAPAs with FDA expectations for effectiveness and sustainability

Final Wrap-Up – Building Long-Term FDA Inspection Resilience 

• Integrating inspection lessons into daily operations
• Using FDA inspections as a system stress-test
• Moving from inspection anxiety to inspection confidence

This is Module 2 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.