Basic GMP

Understand GMP and learn how companies work with it in practice

This course, including evening activities and overnight stay, provides you with a solid foundation in GMP. You will learn through case work, exercises, and a GMP game. The course also gives you the opportunity to network with others who are new to life science.

GMP (Good Manufacturing Practice) is a set of rules and standards that ensure medicinal products are manufactured consistently and safely. GMP supports quality, traceability, and patient safety.

 

In this course, you will receive a thorough introduction to GMP and the EU rules governing the manufacture of medicinal products. You will gain a basic understanding of requirements, responsibilities and the mindset needed to work in a GMP-regulated environment. You will be introduced to the life science industry and the journey a medicinal product takes to reach the market.

You will explore the link between legal requirements, quality, and patient safety. We take an in-depth look at the EU GMP guidelines (EudraLex Volume 4). You will work with key topics such as the Pharmaceutical Quality System, risk management, requirements for manufacturing, personnel, premises and equipment, and documentation.

 

The teaching alternates between presentations, dialogue, and exercises. You will also take part in an interactive GMP game based on typical day-to-day situations. The game encourages valuable discussions and makes it easier to translate GMP principles into practice.

 

What makes this course special is the format:

On Day 1, teaching runs until 5:00 pm, followed by a shared dinner from 6:00–7:30 pm and then the GMP game.

You stay overnight, and on Day 2 teaching runs from 9:00 am to 4:00 pm. This provides time, energy, and strong networking opportunities—especially if you are new to life science.

All meals and refreshments are included in the course fee.

 

This course can also be conducted on-site at the company - see here

You can find the course in Danish here.

 

Course Responsible:

Tine Gjerding Dahlberg, Educational Consultant, Pharmakon

Course facts
Format
2 days
Rating
4,77 out of 5
Price this year
17.500 DKK excl. VAT, overnight stay included
We are working on finding a new date
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Your advantages when choosing this course

Your benefits

  • you understand the fundamental principles of GMP and the structure of the EU GMP guidelines
  • you can work more confidently with documentation, quality, and GMP requirements
  • you can apply a basic GMP mindset and contribute to ensuring the quality of medicines

Your company's benefits

  • your employee has an understanding of GMP, quality, GMP-mindset, and responsibility
  • your employee works more consistently and correctly according to applicable regulations
  • your employee contributes to improved quality and patient safety
Louise’s engagement in teaching. She made the hours pass by super fast! I also appreciated having frequent breaks, and the structure of the program, with some cases among theory
Course evaluation
Louises passion, excitement and deep knowledge made everything very fun and interesting
Course evaluation
Presentations were clearly structured and communicated. The slides supplemented with booklet is very effective method. Hard to think of improvements. Excellent sequencing of topics to keep interest with more intensive info at start when we are most fresh. Catering, snacks and food is excellent. Makes a difference
Course evaluation

Target group

The course is aimed at academics and technicians who are inexperienced with GMP, as well as new employees in the life sciences industry who need a basic understanding of GMP.

 

It is also suitable for those already working with GMP who want a deeper understanding of the rationale behind their work and the GMP regulations.

Course agenda

The course is a two-day course. Accommodation is included.

 

Day 1: 09.00 – 21.00

  • Introduction to the Life Sciences Industry
  • The Path of a Medicinal Product to the Market
  • Legal Framework and Structure of EudraLex Vol. 4
  • Pharmaceutical Quality Systems and Risk Management
  • Facilities and Equipment

Day 2: 09.00 – 16.00

  • Production and Raw Materials
  • Documentation and Good Documentation Practice
  • Deviations and Changes
  • Personnel, Behavior and Hygiene
  • GMP Mindset in Practice
  • Interactive GMP Game

The course consists of presentations, discussions and exercises.

Date coming soon
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