GMP basics

Good Manufacturing Practice (GMP) danner strukturen for dokumentation inden for Life Science, og det er derved et af de vigtigste værktøjer i branchen for at sikre patientsikkerheden. Kurset vil hjælpe dig med at få det rette GMP-mindset som er en grundlæggende egenskab i branchen.

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Who can participate?

Anyone interested in gaining basic knowledge in GMP.
Quality, production, development, QC (quality control) personnel.
People with positions in the Life Science industry such as:
Technicians.
Operators.
Suppliers to GMP regulated companies.
New or prospective employees in the Pharmaceutical industry.
New or upcoming employees in the Medical Device industry.

Course overview

Confirm Knowledge Center
Havnevej 1, 1 tv, 4000 Roskilde
Danish / English

The teaching material will be in English.
Teaching will be in Danish.

Prerequisites to participate

There are no prerequisites to participate in the course. The course is aimed at both those new to the industry and those with some experience.

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GMP basics

Du en omfattende introduktion til Good Manufacturing Practice (GMP), der er essentiel inden for Life Science-industrien for at sikre patientsikkerhed og produktkvalitet. Kurset dækker de aktuelle europæiske GMP-regler og nøglebegreber og giver dig både teoretisk viden og praktiske færdigheder, som du kan implementere i dit daglige arbejde.

Områderne tæller kvalitetssystemer, pesonalets ansvar og adfærd, udstyr og faciliteter, herunder kalibrering og monitorering, dokumentation og god dokumentationspraksis, afvigelser og afvigelseshåndtering.

Kurset er baseret på den europæisk Eudralex og vores erfaring fra projekter i branchen.

Course information

Teaching method

You will learn how to identify important functions for patient safety, product quality and data integrity, facilitate risk assessments and apply appropriate methods to evaluate risks. The course combines theory, practical exercises and industry examples and is based on ISPE guidelines and GMP.

We encourage ongoing dialog and sharing of experiences to promote learning. At the end of the course, we ask for learner evaluation to improve our teaching.

Course highlights

On the course you will achieve:

In-depth knowledge of risk management principles according to ICH-Q9 and the three risk categories in pharmaceutical manufacturing.
Competencies to assess, analyze and evaluate risks in your work area.
Methods and tools for efficient design and maintenance of regulatory documentation.

Course program

In the course, we go through, among other things:
Regulatory requirements
Pharmaceutical quality system
Quality management and control
Personnel: Organization, responsibilities and behavior
Facilities and equipment
Good documentation practices & quality management systems (QMS)
Deviations, changes & CAPA
Quality risk management (ICH Q9)
Qualification & Validation
Outsourced activities
Complaints, errors and product recalls

After the course

Catering

Morning coffee and light refreshments.
Breakfast and lunch
Afternoon coffee and cake.

Instructors on the course

Nathalie Anastasja Nielsen

Nathalie is part of our validation team and is responsible for the course area on a daily basis. She has several years of experience as a Quality Assurance in pharma and medical devices, and uses this experience in her teaching of GMP. As part of her teaching, Nathalie draws examples from her experience and makes the teaching material more concrete.

Camilla Hjorth Christensen

Camilla is part of our validation team. As a consultant in the pharmaceutical industry, she has a lot of practical experience with GMP and uses this knowledge as part of her GMP training. Camilla incorporates many of her daily issues into her teaching and the course exercises, making them realistic and relatable.

Testimonials from learners

Learner on Introduction to GAMP 5
Really good and professionally strong presentation. The trainer found the right professional level for the group and initiated good tasks and resulting discussions. And super with small breaks every hour.
Learner on Introduction to GAMP 5
Many thanks and much praise to Katrine! As a teacher, you are present, relevant, a skilled communicator and very pleasant. You manage to bring your experience from both teaching and practice into play in the context in which we ask the questions.
Learner on Introduction to GAMP 5
I think it was good to mix the theory and the practical part. The teacher was super good at explaining and super good at pulling out examples that supported the theory.
Trainee at Data Integrity
The benefit of the course is a quick and processed approach to the ISPE guide.
Trainee at Data Integrity
It was a great course that lived up to all expectations. Super good teacher 🙂
Trainee at Data Integrity
Really good course... even after many hours you are still in it... course leader can maintain focus and interest
Course participant at SattLine Programming
A good structure of course material and balance between theoretical material and exercises. The theoretical parts gives food room for more in depth questions of interested.
Course participant at SattLine Programming
Very motivated course-responsible, very pationate and patient.
Trainee at Data Integrity
Good with exercises and quizzes. Good location and delicious food/catering.
Course participant at SattLine Programming
Super teacher 👍😁

Do you have any questions?

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