GMP courses in English, held in Copenhagen
Day courses for people working in Danish pharmaceutical and life science production, and for the companies that employ them. Taught in English, in Copenhagen.
Built by people from the industry
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GMP courses for every role
Operators, technicians, engineers and more
Why people choose our GMP courses
The rules are explained by people who have worked under them, with time to ask what matters in your own department. The three courses below are all taught in English.
Experience from the industry
Our trainers have worked in Danish pharmaceutical companies, under the rules they teach. Examples come from real situations, so the theory connects to the working day you already know.
Updated with the current rules
Course material is revised as legislation and the expectations of the Danish Medicines Agency change. You get the requirements as they stand now, not theory that has aged.
Central Copenhagen, or online
Our rooms are a short walk from public transport in Copenhagen NV. A programme built for your company can also be held at your own site, or online.
Find the GMP course
that fits you
Our courses are taught by people from the Danish pharmaceutical industry. They are taken by laboratory technicians, operators, engineers and whole quality departments. Three of them are available in English.
Meet some of our trainers
Rikke Egeberg Tankard
Rikke combines an academic background with experience from the industry itself. She holds a PhD in Physics from DTU and most recently worked as equipment specialist at Novo Nordisk, focusing on cleaning processes including Clean-In-Place. There she worked with production equipment, operations, data handling and maintenance. She knows the GMP requirements from the inside, and teaches with a focus on making complex rules understandable and usable.
Lykke Erichsen
Lykke has worked as a Quality Laboratory Technician at ALK and as Instrument Coordinator at FUJIFILM Diosynth Biotechnologies, coordinating service, troubleshooting and GMP documentation for analytical equipment in quality control and production. She teaches with a focus on the everyday reality of the laboratory, and there is always room for questions.
Good Manufacturing Practices, from the rulebook to the production floor
Good Manufacturing Practice is the set of regulatory requirements that keeps pharmaceutical production consistent, documented and safe to release.
It covers quality management and quality assurance, the qualification of equipment, the control of the production environment, and the handling of raw materials and finished products. Our courses give you a solid foundation in those requirements, and in what they ask of your own role.
Frequently asked questions
about our GMP courses
Answers to what we are asked most often.
Can the courses be built around our company?
Yes. We often run GMP programmes built for a single company, working from your own processes and your own requirements. Get in touch and we will talk through what would suit your team.
Which GMP course should I choose?
It depends on your experience and on what you want from it. If you are new to GMP, we recommend the foundational course. If you already work under the rules, an annual update is usually the better fit. Get in touch and we will point you in the right direction.
How does a GMP course help people work consistently and under control?
A GMP course teaches you to follow the established guidelines for quality management and production. Standard Operating Procedures applied correctly, together with systematic handling of production equipment, are what keep a manufacturing process consistent and safe.
How is the teaching run?
It depends on the course. The day courses are taught sessions: a walkthrough of the rules, real examples from Danish pharmaceutical production, and room for questions throughout. A tailored programme is built around your own processes, and it can be held at your site or online.
An overview of GMP and what the courses cover
Good Manufacturing Practices (GMP) are the guidelines a pharmaceutical manufacturer must follow for a product to be released to patients. In Denmark they follow the EU rules in EudraLex Volume 4, and compliance is inspected by the Danish Medicines Agency. The same principles apply whether you work in production, in a quality control laboratory, or with the equipment behind them.
What GMP covers in practice
Five areas run through every part of a regulated production site, and every one of our courses returns to them.
The core elements of GMP are:
- Quality management. Every process and control is documented and carried out systematically, including how raw materials are received and handled.
- Personnel. Everyone is trained for the role they hold, and that training is documented so it can be shown at an inspection.
- Facilities and equipment. Rooms are classified, heating, ventilation and air conditioning and water systems are controlled, and equipment is qualified, calibrated and maintained.
- Documentation. Records are accurate and traceable, so an inspection can follow what happened, when, and who was responsible.
- Production processes. Manufacturing follows defined procedures and established practice, so output is consistent from batch to batch.
The scheduled courses are not available as an online course. A tailored programme for a company can be delivered online if that suits the team better.
We also run GMP for technicians and engineers, and GMP in laboratories and quality departments. Those two are taught in Danish only. If your team needs either of them in English, that is one of the things we can build into a tailored programme.
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