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
Lesson 3: Which Businesses are Subject to Compliance Inspections and External Audits?
Lesson 4: Who Monitors and Audits GMP Compliance?
Lesson 5: Types of Regulatory Compliance Inspections
Quality Systems Review
Frequency of Inspections
Lesson 6: FDA Guidelines for Compliance Inspection and Audit Strategy