Annual GMP training for companies
Build this year's GMP update around the audit findings, deviations and operational changes your teams are facing right now. Pick the topics you already know you need, or start with a free conversation where we work out together where the real gap is.
Location:
At your site, or Copenhagen
Next start date
Flexible
Price:
Depends on scope
Six topics, combined your way
Six topics and their subtopics that most companies build their annual update from. Pick the ones that match this year's audits, deviations and priorities, then combine them into the format that fits. A session runs from two hours, and how deep each topic goes is up to you.
Who is it for?
Teams that already work in a GMP regulated environment. Operators and production staff who follow the procedures. Technicians and engineers who keep the equipment inside them. Laboratory staff who produce the data. And the QA and production managers who have to show, at an inspection, that all of them were trained on the current requirements. Each group can take a different set of topics, so one site can run several updates that fit together.
How we build it
If you already know what you need, pick the topics and tell us how long and how often. If you do not, we start with a free conversation about your goals and where your people stand today. You can send your own procedures, last year's deviations or the findings from an audit, and we build the content around them. We then propose the topics, the length and the structure, and you decide. Nothing is bought before that conversation has happened.
Annual GMP Training Built Around Your Current Challenges, Not a Fixed Syllabus
Most departments do not need a full day on everything. They need the topics their last audit, their deviations and their recent changes are pointing at.
So you choose. Pick from six topics, each with its own subtopics, and decide how long and how often. Some teams need two focused hours, others plan several sessions through the year. If you are not sure where the gap is, we start with a free conversation and work it out together.
What you get back is a session your team recognises from their own working day, and a course certificate for each participant that goes straight into the training file.
Fill in the form and we'll get back to you as soon as possible.
Tell us briefly what your team needs, or what your last audit pointed at. We will come back to you and set up a free conversation.
Plan this year's update with us
Location:
At your site, or Copenhagen
Duration
from 2 hours
Price
Depends on scope
Meet your trainers
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.
Choose the depth your situation calls for
Sometimes two hours on one topic is all that is needed. Sometimes a recurring issue needs a longer session with the right people from across the site. You decide what goes in, how long it runs and how often. We help you get the balance right.
Good documentation practice and data integrity
- Applying ALCOA+ to the records your team writes every day
- Correcting an entry the right way, on paper and in systems
- The documentation errors that come up most often in daily work
- Logbooks, batch records and traceability from start to finish
Deviations, root cause and CAPA
- Recording a deviation so QA can act on it first time
- Finding the real root cause, not the nearest one
- When "human error" is an acceptable root cause, and when it is not
- Writing CAPAs that change the work, and checking that they worked
Updates to the GMP rules and legislation
- What has changed in EU GMP since your last update, and what is on its way
- What inspectors currently ask for, and where they find gaps
- Where responsibility sits, for management and for the individual employee
- How a department stays ahead of the requirements rather than behind them
Behaviour, hygiene and the quality mindset
- Correct behaviour and personal hygiene in classified areas
- Preventing contamination between products and batches
- What a quality mindset looks like in the small decisions on a shift
- Real examples of how behaviour affects patient safety
GMP Fundamentals
- The core GMP principles, and the patient risk each one protects against
- Who owns what: the responsibilities of production, QC and QA
- Closing the gaps where a rule is applied differently across shifts
- Knowing when to stop and escalate
Change control and risk based decisions
- What counts as a change, and why small changes still need control
- Assessing the risk of a change before it is made
- Scaling the effort to the risk
- Closing a change properly: training, documents and effectiveness check
Frequently asked questions about our courses and working with us
Different needs bring different questions. We have gathered answers to the most common ones, and we are always glad to answer more and talk through what your team needs.
Can we choose the topics ourselves?
Yes. Pick one or more of the six topics and combine them the way that suits your team. If you are not sure which topics you need, we work it out together in an introductory call.
How long does it take?
A session starts from two hours. How long it runs depends on how many topics you choose, how deep you want to go and how many teams take part. Some companies plan several shorter sessions through the year instead of one long day. We have a strong team of trainers, so the date is planned with you rather than taken from a fixed course calendar.
Can it go into our training records?
Yes. Each participant receives a course certificate showing that they took part and what was covered, which you can file and show at inspection. EU GMP asks for continuing training and for its effectiveness to be assessed. How the session fits your own training programme is your decision, and we build the content to match it. A course certificate is not a GMP certification. Those are issued to sites by the authorities after inspection.
Can you build it around our own procedures and deviations?
Yes. Send your SOPs, recent deviations or audit findings before we meet, and we build the examples around them. Working from your own documents is usually what makes a session land with the team.
Where is it held, and how many can take part?
At your site, in our rooms in Copenhagen, or online. The session runs in English or in Danish. There is no fixed limit on participants. For large groups across several sites, online is usually the easiest way to reach everyone.
What does it cost?
It is priced after the first call, because the topics and the length decide it. There is no price per seat, because there are no open seats. You are buying a closed session for your own people.
We are here to help
Not sure about something?
Fill in the form and we will come back to you as soon as we can.