This course provides practical guidance on how to prepare your organisation, host the inspection process, and respond effectively after the inspection. A key strength of the course is the combination of practical industry experience and direct authority insight from an experienced GMP Inspector from the Danish Medicines Agency.
Regulatory GMP inspections place high demands on your organisation before, during, and after the inspection. This course gives you practical tools to prepare your organisation, host the inspection in a structured and professional way, and follow up effectively afterwards.
A key strength of the course is the combination of two perspectives. You will gain practical input from an experienced GMP and Quality consultant and direct authority 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 turn regulatory expectations into practical action you can use in your daily work.
The course language is English.
At the course you will meet:
Henrik Thrane, Principal Consultant, Compliance360 - Quality & GxP Consultancy
Thomas Vestergaard Pedersen, Team Leader & GMP Inspector, Danish Medicines Agency
