Good Manufacturing Practice course
An introduction to the GMP rules for people who work in, or are moving into, pharmaceutical production. You get an overview of the documentation requirements, the production environment and the behaviour expected of you, and you leave knowing what working in compliance asks of your own role. No previous GMP experience is needed. You can choose to be taught in English or Danish.
Location:
Svanevej 22, Copenhagen NV
Next start date
27 October
Price:
kr. 5900 (ex. moms)
The Good Manufacturing Practice training that ties the rules to your daily work
GMP is not only a set of rules. It is the way work is organised in a regulated company, from how a document is corrected to how you move through a classified area.
The course is built for people who need the whole picture rather than one corner of it. You do not need previous GMP experience, and you do not need to work in quality to get something out of the day.
We go through the rules and the reasoning behind them, using situations from Danish pharmaceutical production. There is room for questions throughout, and you receive a course certificate for attending.
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Location:
Svanevej 22, Copenhagen NV
Duration
1 day, 9am to 4pm, lunch included
Price
kr. 5900 (ex. moms)
See how our Good Manufacturing Practice course is built
The course covers four subject areas that together give you an overview of GMP in a production company. You start with the rules and the legislation behind them, move on to documentation and how deviations are handled, then to the production environment and hygiene, and finish with behaviour and the mindset the industry expects. The topics below show what each area contains.
Who is it for?
The course is for you if you work in, or are moving into, a production company in pharma or life science. It is most relevant if you are an operator, a production employee, or hold a role in or close to a GMP-regulated environment and want to understand what the requirements mean for your daily work. No previous GMP experience is needed. The course starts from the beginning.
Do you need to train a whole team?
If a whole team needs the same understanding, we can adapt the course to your working day. That can mean using your own documents and processes as examples, or shifting the weight towards the topics that matter most in your department. We always start with an informal conversation about your goals, where your people stand today, and the areas you want to strengthen. The programme is built from there.
Mød dine undervisere
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.
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.
GMP rules, legislation and compliance
- Insight into the GMP rules and what they require in daily work
- Requirements under Danish and international legislation
- Quality management systems and what they are for
- What working in compliance means, and how it is achieved
Documentation and handling of deviations
- Good documentation practice in a regulated company
- Handling SOPs and other controlled documents
- Correct handling of errors and corrections in controlled documents
- Deviations and change control
Production environment and hygiene
- Introduction to microbiology and production hygiene
- Room classification and the requirements that follow from it
- Environmental monitoring
- Disinfection and sterilisation processes
Behaviour and the GMP mindset
- Requirements for behaviour and personal hygiene in classified areas
- Handling of production materials
- The pharmaceutical industry and how its departments are built
- The good GMP mindset, summarised
What the course gives you
You leave with an overview of how GMP fits together in a production company: what the rules require, how documentation and deviations are handled, and what good GMP behaviour means in practice. You will be able to read a procedure and see what it asks of you, and to recognise when something in your own department is drifting away from what was written down. You receive a course certificate, which your employer can keep in its training documentation and show at an inspection. It is not a certification, and no provider can certify a person in GMP.
What Good Manufacturing Practices are, and who sets them
Good Manufacturing Practices (GMP) are the regulatory requirements a pharmaceutical manufacturer has to meet before a product can be released. In Denmark they follow the EU rules in EudraLex Volume 4, and compliance is checked by the Danish Medicines Agency at inspection. The requirements cover quality assurance, documentation, the production environment, personnel and equipment, and they apply to organisations of every size.
Regulations of this kind are written to be read by an inspector, which is part of why they are hard to get started with. The course translates them into what they mean at a bench, at a machine and in a logbook.
Why companies send a whole department
A procedure is only followed the same way by everyone if everyone understands why it exists. A requirement that is understood is applied more consistently than one that has only been read. That is the argument for teaching quality standards rather than circulating them, and consistency is what an inspection is looking for.
Participants often come as a group from the same department, so that the language they use afterwards is the same. The course is also open to individuals, and both work.
What this course does not cover
This course is an introduction to the requirements, not a specialist course. Equipment qualification and validation are covered in depth on our course for technicians and engineers. Laboratory documentation, analyses and raw data are covered on our course for laboratories and quality departments. Both of those are taught in Danish only.
The scheduled courses are not available as an online course. A programme built for one company can be delivered online if that suits the team better.
Related courses
- GMP for technicians and engineers. One day, in Danish. Equipment, maintenance, calibration, traceability, qualification and validation.
- GMP in laboratories and quality departments. One day, in Danish. Quality management systems, analyses, raw data, logbooks and behaviour in the laboratory.
- Annual GMP training for companies. From two hours, in English and Danish. An update for a team that already works under the rules.
Ofte stillede spørgsmål om vores GMP-kurser og samarbejds-muligheder
Med forskellige behov følger forskellige spørgsmål. Vi har samlet svar på de mest almindelige, men står altid klar til at besvare yderligere spørgsmål og drøfte jeres konkrete behov.
What is a foundational GMP course?
It gives you a working knowledge of Good Manufacturing Practice, the rules that keep quality and safety under control in the manufacture of medicines. You get a grounding in the EU GMP requirements and in what they ask of you in your own role.
Who is the course aimed at?
It is aimed at new employees and others working in, or moving into, a production company in life science. It suits operators and production employees who want a solid GMP foundation before or alongside the work itself.
Which topics does the foundational GMP course cover?
Four subject areas: the GMP rules and compliance, documentation and handling of deviations, the production environment and hygiene, and behaviour and the GMP mindset. The teaching combines the rules with real examples from Danish pharmaceutical production.
How does the course support our quality work?
Employees decide whether the quality of a medicine holds. The course teaches you to understand the rules and to handle raw materials, equipment and documentation correctly, which raises quality and lowers the risk of deviations.
Do I need GMP experience to attend?
No. The course is built for experienced employees and for people with no previous GMP knowledge. You get a walkthrough of the GMP requirements and of the situations you meet in an ordinary working day, so you leave understanding the principles.
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