GDP Courses
Strengthen your employees’ competencies with a GDP course
GDP courses can be essential to retaining your GDP authorisation or, if you are a transport provider, to working with GDP customers. At the same time, an in-house GDP course can create a shared understanding and ensure that everyone works in the same direction.
Regular training ensures that managers and employees:
- update and refresh their knowledge
- discuss everyday dilemmas
- are challenged to assess whether procedures and processes are good enough
Your GDP course will be delivered by me, Kiki Atting Andersen, one of Denmark’s most specialised GDP experts.
I have many years of training experience. I teach at Pharmakon, which hosts open-company courses, as well as in pharmaceutical manufacturing companies and in warehousing, distribution and transport organisations.
You can book me for the basic GDP course, or I can tailor a GDP course to your specific needs. A combination of the two is also possible.
The basic course covers the core elements of GDP legislation at an overall level while allowing me to explore selected topics in greater depth when you have specific needs. We agree on this when you book the course.
When we needed a permanent trainer for Pharmakon’s GDP courses in the summer of 2022, Kiki stepped in immediately with wonderfully positive energy and, not least, a wealth of professional experience. Course participants have agreed that Kiki is the right choice of trainer because of her extensive knowledge and enthusiasm for sharing it.
Comments from GDP courses delivered by Kiki include:
- Kiki was the best trainer. A good presentation with strong examples.
It is wonderful that a somewhat heavy subject can be presented and explained with such enthusiasm. It was damn good. - Very educational, with plenty of examples that make it relatable to real life.
- A very good overall review. It was clearly communicated what is critical and required in relation to GDP.
The common theme in all the comments is enthusiastic communication of the requirements, the sharing of many practical examples and clear communication of the critical areas within GDP.
I look forward to offering many more GDP courses at Pharmakon with Kiki as the trainer.
Mette Rotne
Head of Education, Life science
Pharmakon A/S
Basic GDP Course: Program
The basic course consists of theoretical presentations, brief questions along the way and a concluding quiz. The standard programme is as follows:
09.00: Welcome, introduction and brief presentation
09.15: Legislation, quality systems, personnel, premises and equipment
- The legislation governing GDP, including the Danish Medicines Act and Good Distribution Practice, the differences between Danish and European law, and the differences between authorisations for human and veterinary medicines.
- Requirements for company quality systems, including procedures, risk management, change controls and continuous improvement, to ensure that medicinal products are handled in accordance with GDP.
- Rules governing how personnel must be educated and trained in relevant GDP requirements, and how roles and responsibilities are defined.
- Requirements for premises and equipment to ensure that medicinal products are stored and handled correctly, including temperature control, access control and pest control.
10.45: Complaints, internal activities, outsourced activities, self-inspection and transport
- Established procedures for handling complaints, returned goods and suspected falsified medicines, including preventing falsified medicines, recalls and the process for returned medicines.
- Processes for internal activities such as receipt, storage, picking and distribution. Traceability and control throughout the chain are key requirements and involve extensive documentation.
- Quality agreements for outsourced activities that describe responsibilities and requirements, primarily in connection with warehousing and transport.
- Regular self-inspection to ensure compliance with GDP procedures, document results and follow up where necessary.
- Specific transport rules to preserve the quality of medicines during distribution, including temperature control, documentation and the selection of transport solutions.
12.00: Final quiz, testing your knowledge and reviewing the answers
12.30: Thank you for today, and hopefully see you again
Extended GDP Courses: Full-Day Course or Specialist Course
You can extend the basic course into a full-day course, allowing us to explore selected topics in greater depth or include new ones. This format provides more opportunity for dialogue, discussion and ongoing elaboration when questions arise. Alternatively, you can book a course tailored to your specific needs if your employees already have a solid understanding of the basic-course topics.
Additional topics may include:
- Detailed quality-system requirements
- Personnel training, particularly for key personnel
- Requirements for the RP and management
- Export and import
- IT systems, supplier qualification and system validation
- Good documentation practice and double-checking
- Self-inspection, audits of contract acceptors and GAP analysis
- GDP for APIs
- Documentation requirements relating to controlled substances
We can also review how you:
- Manage deviations, minimum requirements and expectations
- Implement effectiveness checks
- Assess risks
- Optimise management review
- Qualify suppliers and customers
- Recall or destroy medicines
I met Kiki being a Responsible Person for a MAH holder. Kiki is well aware of the GxP regulation and knows how to implement this in a pragmatic and efficient way for her customers. Her enthusiasm and humor make the air around her very light.
Ingeborg Baars
Sr. Consultant & Owner
Baars Consultancy, NL
Extended GDP courses are based on your company, everyday work and specific challenges. This means we can include relevant cases tailored to your reality. We can also finish with a quiz, or include group work throughout the course to work directly with the GDP material. Almost anything is possible on these courses, and they provide a welcome opportunity to spend an enjoyable day exploring the requirements of the GDP world together with colleagues.
In addition to the open courses at Pharmakon, I have delivered training at: Amgros/Regions of Denmark, Ascendis Pharma, B. Braun, Bavarian Nordic, Caldic, Freja Transport & Logistics, Kuehne & Nagel, LEO Pharma, Medilink, Mission Pharma, Movianto, NTG Neptun Transport, Novo Nordisk, Pharma IT, Pharmanovia, Serwiz, Sodexo, Statens Serum Institut, Vilovet, Y-mAbs and Aalborg Hospital Pharmacy.
Hør mere om GDP-kurser
Vil du høre mere om mulighederne for et GDP-kursus? Eller er du klar til at tage en konkret snak om, hvordan jeres GDP-kursus skal planlægges, og hvad deltagerne skal have ud af det?
