The Use of Artificial Intelligence in Qualification and Validation
Wednesday, 24 September 2025 9 .00 - 15.45 h
Course No. 22271
Speakers
Dr Rainer Gnibl
GMP Inspector
Ralf Gengenbach
gempex
Alejandro Parisi
Roche Diagnostics
Objectives
A GMP inspector establishes the necessary regulatory framework so that artificial intelligence can be used in a GMP-compliant manner. He will provide an insight into the planned changes to Annex 11 and discuss the new Annex 22 on artificial intelligence. An industry representative will then give an overview of the possible applications of artificial intelligence in the area of qualification and validation. Current practical experience in the pharmaceutical industry will be discussed. Another industry representative will then present the use of artificial intelligence in equipment qualification in a "live performance". He will also highlight potential savings. Two question-and-answer sessions will provide the opportunity to discuss this complex topic.
Background
Hardly any other topic is currently being discussed in the pharmaceutical industry as much as the use of artificial intelligence. The potential applications appear to be vast, the uncertainty even greater. There are a lot of terms "buzzing around": artificial intelligence vs. machine learning vs. deep learning. There are Questions:
How to ensure data integrity in the field of artificial intelligence?
What regulations on artificial intelligence actually exist?
What roles do GAMP 5 Annex 11, the EMA reflection paper on artificial intelligence and the upcoming Annex 22 on this topic play?
What tests are necessary to be able to use artificial intelligence?
What possible applications are there in the area of qualification and validation?
Where are the limits to the use of artificial intelligence?
What framework conditions must be in place in the company so that artificial intelligence can be used in compliance with GMP?
The one-day online compact seminar "The use of artificial intelligence in qualification and validation" aims to help clarify these Questions.
Target Group
It is aimed at those interested in the use of artificial intelligence in the field of qualification and validation, but who also want to know which requirements are necessary from an official point of view before use. Explicitly addressed are e.g. quality management/quality assurance managers, validation officers, production managers, etc.
Date & Technical Requirements
Date of the Live Online Training Wednesday 24 September 2025, 09.00 - 15.45 h All times mentioned are CEST.
Technical Requirements We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Testimonials
Seminar Programme as PDF