Date

Monday, July 6th 2020 - Friday, July 17th 2020

Location

Antwerpen, België

Price

€2995.00 for non-members

€2745.00 for members

Language

English

Organised by

Helis Academy

Categories

Tags

Always wanted to work in the pharmaceutical industry, but lacked the necessary experience? With this ten-day course 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

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).

Practical information

When? From 6-10 July 2020: module 1-5. From 13-17 July 2020: module 6-10.

Where? Quality by Design NV, Fotografielaan 5, 2610 Wilrijk, Belgium. Except for module 3 and 4 (8-9 July), which will take place at Advipro, Wechelsebaan 143 Unit 13, 2275 Lille, Belgium.

Registration fee? The registration fee for the ten-day course is €2745 (excl. VAT) for members and €2995 (excl. VAT) for non-members. The registration fee for students and job seekers (private rate) is €495 (excl. VAT).

Registrations are closed.

Programme

  • Module 1: Introduction to Good Manufacturing practices (GMP)

  • Module 2: Quality management system and documentation

  • Module 3: Contamination control: infrastructure - staff - cleaning

  • Module 4: Aseptic techniques

  • 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

Partners

Terms and conditions

Performance of services

Flanders.bio and partners - QbD, Q-people, Advipro and BTF Leiden - commit to perform the agreed training (GMP course for academics and professionals) to the best of their ability. In case of insufficient participation in or in case of force majeure prior to or during this training, flanders.bio has the right to cancel the course or to move it to a later time. For practical reasons, the maximum number of participants is limited to 15. The minimum number of participants to commence the training is 8. When cancelled or postponed to a later date, any registration fees paid will be refunded.

Cancellation policy

Only written cancellations will be processed. If cancelled more than 20 days prior to the first day of training, an administration fee of €45 will be charged, except for students and job seekers. In case of cancellation on or after 20 days prior to the first day of training, the full registration fee will be charged. Upon premature termination of participation to the multi-day course, registration fees will not be refunded.

No show

If you are not present at the training or do not cancel in time, the full registration fee will be charged.

Replacement

When unable to attend, a colleague can take your place. Report your hindrance and/or replacement of participation to flanders.bio as soon as possible. Replacement after the start of the training is not possible.

Registration fee

The registration fee for the ten-day course is €2995 (excl. VAT). The registration fee for students and job seekers (private rate) is €495 (excl. VAT).

Certificate

At the end of the ten-day training, participants who have followed all modules will receive a participation certificate.