GAMP 5 for suppliers

How to meet the expectations pharmaceutical manufacturers have of computerized systems providers.

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Who can participate?

The course is for engineers, technicians, chemists and others who work in companies that supply the pharmaceutical industry with machinery and equipment containing computerized systems.
Automation and IT engineers
Project engineers and managers
QA employees and managers
IT managers
Machine builders and robot suppliers

Course overview

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

Prerequisites to participate

There are no prerequisites other than an interest in understanding how GAMP as a tool can benefit suppliers of automated systems that must comply with current GMP regulations.

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GAMP 5 for suppliers

GAMP is a recognized approach in the pharmaceutical industry that ensures a logical and systematic approach to categorization, documentation and risk assessment of automated systems. Our course focuses specifically on how you as a supplier can meet the requirements and expectations of pharmaceutical manufacturers by ensuring product quality, data integrity and patient safety in the systems you deliver.

Course information

Teaching method

The training combines theory with practical examples and exercises based on industrial practice. We encourage continuous dialog and sharing of experiences to increase understanding and learning. At the end of the course, we always ask for student evaluation to ensure continuous improvement.

Course highlights

On the course you will achieve:

Understanding GAMP 5 to avoid misunderstandings and misinterpretations.
Knowledge of software categorizations, documentation requirements and risk management.
Insight into customer expectations for design specifications and documentation quality.

Course program

After the course

Have an overview of applicable GMP rules and guidelines.
Have the skills to plan, develop and test systems in accordance with requirements
Understand risk management in relation to patient safety, product quality and data integrity.
Do you have the ability to meet customer expectations for automation best practices.

Instructors on the course

Jeppe Lunde Schmidt

Jeppe works in our validation team on a daily basis and has been teaching for several years. He has worked with and validated several different types of IT equipment, from simple transmitters to large complex IT systems.

Katrine Rivière

In addition to teaching, Katrine works as Engineering Manager at Confirm. Her interest in sharing methods and concrete tools is based on Katrine's own experience as a consultant in the pharmaceutical industry. The course participants particularly value her ability to understand customers' problems, as well as her ability to make complex problems concrete and show examples of how to solve them operationally.

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 on 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 on 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 on SattLine programming
Super teacher 👍😁

Do you have any questions?

Contact us

If you have any questions regarding our courses, our employee Sabrina is ready to help you. Contact Sabrina