IT / OT Infrastructure Qualification and Operation in a GMP Environment
22-24 May 2024, Copenhagen, Denmark
Course No. 21084
Speakers
Dr. Bob McDowall
R.D. McDowall Ltd.
Yves Samson
Kereon
Frank Behnisch
CSL Behring
Note: All times mentioned are CEST.
Objectives
Get an overview of technologies discussed currently in the pharmaceutical environment
Learn what requirements are placed on the IT infrastructure and its qualification within the scope of GMP regulations
Principles outlined can be applied to Operation Technology (OT) for production systems
IT security and cybersecurity has now taken on a central role; here you will learn about the importance of the IT infrastructure in terms of an appropriate IT security concept
Case studies show you qualification approaches for key IT infrastructure components
Virtualization is a part of the IT infrastructure; learn strategies for qualifying the virtual machine and the virtualization platform
Background
In today’s pharmaceutical environment, the IT infrastructure is the backbone for the application of a wide range of software solutions. The requirements for IT security are becoming increasingly important. Only a robust IT infrastructure with suitable network topologies and security concepts can guarantee the appropriate security here.
Pharmaceutical regulations contain few or only indirect requirements for the IT infrastructure. The principles of the EU GMP guidelines state “The application should be validated, the IT infrastructure should be qualified”. Here the phrase “should” corresponds to a “must”! Further information can be found in the revised version of the GAMP® Good Practice Guide “IT Infrastructure Control and Compliance” published in August 2017.
Target Group
The Event is aimed at managers from the pharmaceutical industry, suppliers and service companies who plan, qualify and operate IT infrastructure in a GxP Environment.
Testimonials
Seminar Programme as PDF