Mastering GMP Inspections

Regulatory GMP inspections place high demands on your organisation before, during, and after an inspection. This course provides you with practical tools to prepare your organisation, manage the inspection in a structured and professional manner, and follow up effectively afterwards.

A key strength of the course is the combination of two perspectives. You will gain practical insights from an experienced GMP and Quality consultant, as well as direct regulatory insight from an experienced GMP Inspector from the Danish Medicines Agency. This gives you a stronger understanding of both inspection readiness and inspector expectations in practice.

You will learn how to prepare your organisation, documentation, systems, and facilities for inspection, how to communicate and act during the inspection, and how to respond clearly and effectively afterwards. Through expert input, real-life cases, discussions, and exercises, you will translate regulatory expectations into practical actions that you can apply in your daily work.

The course spans two days with an overnight stay, which provides time and space for reflection, immersion, and networking across participants—and thereby significantly enhances your overall learning outcomes.

Your benefits

• You will prepare your organisation for regulatory GMP inspections.
• You will host inspections and communicate professionally with inspectors.
• You will respond effectively to findings and follow-up requirements.

Your company's benefits

• Your employee improves readiness for regulatory GMP inspections.
• Your employee handles inspections in a more structured and professional manner.
• Your employee strengthens responses, follow-up activities, and organisational learning.