Regulatory Compliance Inspections and External Audits

Compliance with guidelines established by regulatory agencies such as the FDA and WHO is a core requirement of Good Manufacturing Practice (GMP).

This course introduces the fundamentals of regulatory inspections and audits, including why they matter, how they are conducted, and the role of regulatory bodies in ensuring safe, compliant manufacturing.

Developed by Regulatory Affairs experts trained at Northeastern University and guided by a senior industry specialist, the course delivers a clear, practical overview of inspection readiness.

🚀 Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

✅ Who should enroll?

• Quality Assurance and Quality Control professionals
• Regulatory Affairs and compliance specialists
• Manufacturing and operations teams
• GMP audit and inspection readiness personnel

 
🎯 What you’ll learn?

• Understand the purpose of regulatory inspections and external audits in GMP environments
• Identify the agencies responsible for monitoring compliance (FDA, WHO)
• Recognize the different types of inspections and what each evaluates
• Prepare for FDA inspection expectations across key quality systems
• Strengthen inspection readiness and support continuous GMP compliance

Curriculum

 
Introduction
 
Lesson 1: Why are Regulatory Compliance Inspections and External Audits Important?

Lesson 2: The ICH Q10 Guidelines on Regulatory Inspections

• Achieve Products Realization
• Establish and Maintain a State of Control
• Facilitate Continual Improvement

Lesson 3: Which Businesses are Subject to Compliance Inspections and External Audits?

Lesson 4: Who Monitors and Audits GMP Compliance?

• Regulatory agencies responsible for GMP Audits

Lesson 5: Types of Regulatory Compliance Inspections

• Routine Inspection
• Concise Inspection
• Follow-up Inspection
• Special Inspection
• Quality Systems Review
• Frequency of Inspections

Lesson 6: FDA Guidelines for Compliance Inspection and Audit Strategy

• Quality system
• Inspection of Quality System (Phase 1 and Phase 2)
• Product Reviews
• Compliant Reviews
• Discrepancy and Failure Investigations (for manufacturing and testing)
• Change Control
• Product Improvement Projects

Glossary

Quiz