HELIS Academy GMP Course: Level I

Short description

(This project is financed by the European Fund for Regional Development. This project is co-financed by the Dutch Ministry of Economic Affairs and Climate Policy and the Province of South Holland.)

Important Notice: 

Because of COVID19 we had to adjust the program to limit the number of contact moments. Therefore, the theoretical part will be given as E-learning. We also schedule a session where you can ask questions to our GMP trainer about the topics you have studied. Additionally there will be a Fermentation Webinar and a full day of practice.

The planning is as follows: before the 1st of May you will receive login details for the E-learning modules.

May 10: Webinar about the Fermentation Process and a Questions & Answers session with the GMP trainer

May 12: Day of practice at Biotech Training Facility in Leiden

Introduction course content: The production of medicines is a profession with its own challenges. Medicines must meet high standards before they can be administered to patients. This means, among other things, that medicines are manufactured in a very clean environment where strict quality controls are in place. The guidelines for the production of medicines have been laid down by the EU as Good Manufacturing Practice (GMP).

This course covers the essential aspects of (bio)pharmaceutical manufacturing. Through lectures, practical lessons, workshops and guided tours, you will get a complete picture of, and good insight into all things related to GMP. Biotech Training Facility has a fully equipped pharmaceutical plant, which means that you will be able to instantly apply the acquired knowledge, in a realistic working environment.

When you are interested in a job that involves production or packaging this course provides a good basis for a job in the biotech or pharmaceutical industry.

Objectives

Through lectures, practical lessons, workshops and guided tours you will get a complete picture of and a good insight into the topics below:

Introduction to GMP: You will first become acquainted with the principles of Good Manufacturing Practice (GMP). This knowledge will be immediately put into practice in order to gain a good insight into the role and importance of GMP.

Contamination control: A GMP production takes place in a controlled environment aimed at preventing contamination of the product. Production personnel work in cleanrooms and wear protective clothing. There are many kinds of measures with regard to the design of production areas, the use of materials and staff behavior.

Manufacturing: You will learn about and experience the different phases in biopharmaceutical production, including fermentation, chromatography and aseptic techniques. Again, the training starts with a theoretical part and continues with practical assignments to gain experience in a real-life production environment.

Target group

This GMP-course is suitable for anyone who wants to know more about the pharmaceutical production industry and wants to work in a production environment..

The Level I GMP course is aimed at starters in the Health & Life Science industry. You have no background in Life Sciences? So far, you have only worked in other sectors? Is the world of medicine completely new to you? Then this course is the most suited for you. In this course you will be introduced to the industry and production of medicines. The course is a first step in preparing you for a job in production or packaging of medicines.