Temperature-controlled GMP storage

Ensure proper handling of temperature-controlled GMP storage.

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Who can participate?

Process technicians and chemists
Project engineers and managers
QA employees
Machine suppliers
Others with interest in thermal validation

Course overview

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

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

Prerequisites to participate

There are no prerequisites to attend the course other than an interest in better understanding storage facilities in the pharmaceutical industry.

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Temperature-controlled GMP storage

Only when you have an overview and understanding of the processes involved in the design, qualification and operation of a storage unit can you ensure that you have temperature control that optimally supports product performance and shelf life.

In this course, we follow a typical cycle of a storage unit - designing, qualifying and commissioning temperature-controlled storage. We provide a thorough overview of many of the different systems used for storage, such as refrigerators, freezers, climate rooms and warehouses, and help you understand the regulations that apply to temperature-controlled storage.

Course information

Teaching method

The course alternates between a review of regulations and guidelines in relation to the design and qualification of storage in the pharmaceutical industry and what this means in practice.

During the course, you will be presented with exercises and cases that reflect real-world issues.

Course highlights

On the course you will achieve:

Fundamental understanding of the design, construction and qualification of storage facilities.
Knowledge of the latest regulations and guidelines for storage in the GMP industry, including regulations such as FDA, EMA and ICH.

Course program

Introduction to temperature-controlled GMP storage
Overview of regulations and guidelines
Design; Understanding the pros and cons of different design solutions
Qualification; Overview of qualification activities and how they are performed
Operations; Knowledge of handling deviations, requalification, etc.

After the course

Do you want to be well equipped to participate in the work around storage facilities and help take your department to a higher level?
That there is a good qualification strategy for the department's storage facilities.
That there is proper temperature monitoring in the department's storage facilities.
That you are ready for inspection.

Instructor on the course

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 👍😁

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