HELIS Academy GMP Course

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.

Duration
10 days
Course fee
€ 995 (excl. VAT)
€ 495 (excl. VAT) for private individuals (participant pays)

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)

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.

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.

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 real-life 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 suitable for anyone who wants to know more about the pharmaceutical production industry and wants to work in a development department, production environment or in quality control.

The course is divided into 2 different levels of knowledge and experience in order to ensure that the content is optimally suited to the target group.

Level I (to be scheduled)

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, packaging or quality control of medicines.

Level II (scheduled 19 - 30 Nov 2018)

The Level II GMP course is aimed at graduates (BSc, MSc, PhD and postdoc), who have studied a subject or discipline in Life Sciences, but have no experience in the GMP production industry. 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).

Choose the GMP course that best suits your background.

In order to be eligible for positions in the aforementioned departments, certain background knowledge or experience may be required. Please do not hesitate to contact us if you have any questions in this regard or if you are not sure which level suits you best.

Program

 

Module 1 - Introduction to GMP

Introduction to GMP
Introduction data integrity
Development process in Pharma/Biotech

 

Module 2 - Quality Management System & Documentation

Quality System
Quality Risk Management
Good Documentation Practices
Writing documentation

 

Module 3 - Contamination control: Infrastructure - Staff - Cleaning

Pharmaceutical microbiology
Contamination control: Infrastructure
Contamination control: Personnel
Contamination control: Cleaning

 

Module 4 - Fermentation and aseptic techniques

Aseptic processing
Aseptic techniques
Fermentation process

 

Module 5 - Quality Management System: Deviations, OOS and Change control

Deviations and OOS
Change control
Company visit

 

Module 6 - Raw materials and packaging

Material flow
Materials
Packaging
Packaging Materials

 

Module 7 - Validation

Basic principles of validation
Materials
Process validation
Company visit

 

Module 8 - Quality Control

Analytical methods
API/Drug substance testing
Drug product testing
Stability studies
Basic techniques
Data integrity and OOS

 

Module 9 - Downstream processing (DSP)

Production process/impurity profile
DSP techniques
Virus inactivation
Critical aspects in production
DSP

 

Module 10 - Aseptic manufacturing practice

Preparing for aseptic manufacturing
Aseptic manufacturing (manual)
TSB Media fill with automatic filling line
Visual Inspection

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Interested in signing up a group of people for this course?

Please contact our Business Development team:
info@biotechtrainingfacility.nl
+31 (0)88 2830100

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Know how.
Know why.

Need help? Have a question or a suggestion maybe?

Drop us a line below or call us on
+31 (0) 88 283 01 00.

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