Helis Academy GMP Course for Academics and Professionals

Always wanted to work in the pharmaceutical industry, but lacked the necessary experience? Flanders.bio is organizing ten-day course where you will not only increase your knowledge, but also your practical experience.

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. Advipro has a complete training center with a cleanroom, which means that you can immediately apply the acquired knowledge in a realistic practical environment.

Whether you are interested in a job that involves the development of analytical methods, production, quality control, quality assurance or process development, 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.

• Development process in biotech and the pharmaceutical industry: The different stages of the medicine development process are covered, for instance, the pre-clinical phase, which focuses on dangerous side effects (toxicity), and the various clinical phases in which the drug is tested on humans. The commercial production phase will also be discussed.

• Quality Assurance: Quality must be monitored at every stage of the production process. Processes and equipment must be validated to ensure that everything is working as expected. All procedures and actions are documented. In the case of a deviation, the effects on the quality of the finished product must be examined. At the end of a production, all information is assessed. These tasks are the responsibility of the quality assurance department.

• 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 reallife production environment.

• Quality control: During and after the production of a medicine, quality controls are performed by taking samples and analyzing them using different analytical methods. It is examined whether the product meets all standards and whether there are no contaminants. The products and raw materials, among other things, are analyzed in this way. Samples are also taken from places in the production areas and from the hands of employees in order to detect the presence of microorganisms that could threaten the quality of the product.

Target group

This GMP course is aimed at graduates (BSc, MSc, PhD and postdoc)and professionals, who have studied a subject or discipline in Life Sciences, but have no experience in the GMP production industry. If you want to know more about the (bio)pharmaceutical production industry then this course is something for you. With this course you will gain insight and experience in the pharmaceutical manufacturing industry. You could then qualify for jobs in production, quality control (QC), analytical method development, formulation development or quality assurance (QA).

Programme

Module 1: Introduction to Good Manufacturing practices (GMP)

Module 2: Quality management system and documentation

Module 3: Contamination control: infrastructure - staff – cleaning – Organised by Advipro

Module 4: Aseptic techniques – Organised by Advipro

Module 5: Quality Management System: deviations - OOS - change control

Module 6: Raw materials, packaging/labelling and distribution

Module 7: Validation (Facility/equipment/system qualification and Process validation)

Module 8: Quality Control

Module 9: Downstream processes

Module 10: Aseptic production filling

For more detailed information you can visit the website of Flanders.bio.