You will get an insight into the GMP regulations. We will explore the requirements for the personnel, premises, and equipment as well as the many requirements to documentation. After the course, you will know what working according to GMP means and you understand the mindset it takes to produce safe medicinal products.
In just two days, you will get a basic knowledge of the basic EU-GMP regulations (EudraLex Vol. 4), and you will gain a foundation for understanding the GMP requirements in daily operations. After the course you will be able to participate in practical problem solving when it comes to interpretation of the GMP requirements in your work.
In this course we will explore topics such as quality, risk assessment and personnel behaviour. You will gain knowledge of what is required of premises and equipment to ensure the quality of medicinal products. You will also gain a thorough understanding of the expectations to GMP documentation.
You will be introduced to the GMP regulations through presentations and cases, where you will have the opportunity to discuss how the requirements should be interpreted in practice.
When you discuss the requirements with the other participants, you will gain a broader understanding of how the mindset of the personnel helps ensure compliance with GMP. In this way, you will get both a theoretical and practical basis for understanding and complying with the GMP requirements.
The days are a mix of presentations, exercises, and group work. Various GMP issues are discussed based on cases and experience.
You can find the course in Danish here.
At the course you will meet:
Hanade Bahash, Education Consultant, Pharmakon
Louise Schou Petersen, Education Consultant, Pharmakon
The course is intended for those who have limited GMP knowledge and in need of an overview of the GMP regulations, this course is for you, no matter whether you are supporter, manager or other in a production department, QC or QA.
The course is also relevant for those who already work in a GMP regulated facility and wants to gain insight into the regulations to better understand the implementation of the rules.
The course is a two-day course. Accommodation is included.
Day 1: 09.30 – 21.00
Day 2: 09.00 – 16.00
The days will be a mix of presentations and group work.
Various GMP issues are discussed based on cases and experience.