GAMP 5 AI Accelerated

How to optimize the quality and efficiency of your computerized systems development using Good Automated Manufacturing Practice (GAMP) and artificial intelligence.

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Who can participate?

The course is designed for engineers, technicians, chemists and other professionals in the pharmaceutical industry who work with or are users of computerized systems:
Automation and IT engineers
Project engineers and managers
QA employees and managers
IT managers
Process technicians and chemists
Machine builders and robot suppliers

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

No prerequisites are required, just an interest in understanding the benefits of combining GAMP5 with AI to achieve compliance and efficiency.

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GAMP 5 AI Accelerated

This 2-day course provides you with targeted knowledge of GAMP5's methods combined with practical application of AI tools like ChatGPT. You will learn how the integration of AI can improve product quality, data integrity and patient safety in your systems.

Course information

Teaching method

The teaching combines theory and practice with dialog and discussions based on students' experiences and industrial practice. We encourage end-of-course evaluations to continuously improve our teaching.

Course highlights

On the course you will achieve:

Understanding the principles of GAMP5 and how AI can be integrated to create clear and measurable URSs, minimizing misunderstandings and errors.
Knowledge of software categorization, risk management and how AI can assist in these processes.
Overview of necessary documentation and its effective use with the help of AI.
Insights into optimizing skills and collaboration using AI tools.

Course program

After the course

Implement AI tools into your existing GAMP5 processes to improve efficiency and accuracy.
Create and review documentation using AI, reducing time and increasing accuracy.
Use AI to identify and manage risks and evaluate suppliers in accordance with GAMP5 principles.

Instructors on the course

Jeppe Lunde Schmidt

Validation specialist at Confirm with extensive experience in implementing and validating IT systems in the pharma sector. Jeppe brings practical examples and cases into the training to ensure relevance and applicability.

Katrine Rivière

Engineering Manager at Confirm with in-depth experience in both GAMP5 and AI applications in the pharmaceutical industry. Katrine is recognized for her ability to communicate complex topics in an understandable and practical way.

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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