Regulatory Compliance Inspections and External Audits


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Compliance with guidelines established by regulatory agencies such as the WHO or the FDA is a key aspect to Good Manufacturing Practice (GMP). Compliance is enforced by inspections and audits: inspections evaluate two or more systems in the manufacturing loop; audits confirm that the goals of GMP are being met. In this introduction to the inspection and auditing processes, participants will learn about various types of inspections and about the role of regulatory bodies in ensuring the production of safe and effective drugs and medical devices.


In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.






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
  • Reprocessing
  • Market Returns
  • Rejects
  • Stability Failures
  • Validation
  • Staff Training
  • Facilities and Equipment System
  • Inspection of Facilities and Equipment System
  • Facilities
  • Equipment
  • Materials System
  • Production System
  • Packaging and Labeling System
  • Laboratory Control System






Saher Binte Haider
Saher Binte Haider (PharmD) is a pharmacy graduate from Dow University of Health Sciences. She started her career as a Quality Management professional in the pharmaceutical industry where she developed her interest in good documentation practices, SOP creation, and pharmaceutical regulatory compliance. She has 7 years of experience in medical writing. Her key areas of expertise are pharmaceutical regulatory writing, medical and pharmaceutical research, online content creation and strategy, writing on disease states, and pharmacology.


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