On July 1 and 2, 2026, experts from the pharmaceutical, GMP, IT, and automation sectors will gather for the Pharma “Tech Talk” in Mannheim. This specialized event provides live demos, practical knowledge sharing, hands-on presentations, and engaging discussions on current technologies and their regulatory assessment.
The event will focus on the use of HMI systems (Human Machine Interface) in pharmaceutical and biopharmaceutical production. These systems are considered key infrastructure components that enable access to critical systems. Their reliable and efficient use, including in hazardous areas, is the topic of this technical event. The organizer is Pepperl + Fuchs, based in Mannheim, one of the leading companies in industrial sensor technology and intrinsically safe explosion protection.
gempex will be presenting two technical lectures.
HMIs in the GMP System – Regulatory Fundamentals and Typical Features of Qualification
- Key Points from the EU GMP Guideline
- The qualification process
- Requirements for hardware and software
- GMP in the context of other safety objectives
The speaker is Theresa Rumford, Senior Consultant at gempex GmbH. She has extensive experience in the field of automation within the pharmaceutical manufacturing sector and in the GMP-compliant integration of technical systems. As part of the qualification process, she has also worked extensively with automation and HMI systems.
Data Integrity in Computer Systems – Computerized System Validation
The focus of this contribution is on computerized systems in the production environment, such as PLC and MES, as well as PLC controls, taking into account the entire life cycle. Topics include:
- ALCOA+, Annex 15, GAMP 5
- Fundamentals of IT qualification and IT validation
- User management, audit trail, data security
The speaker is Dr. Georg Schwarz, Principal Consultant for IT Validation at gempex GmbH. He has many years of experience in the validation of all types of computer systems in the life sciences industry. His guiding principles are efficiency and practicality.
gempex looks forward to exchanging ideas with users, technology providers, and GMP experts at the event.
If you have any questions regarding IT validation or GMP in biopharmaceutical manufacturing, our experts are happy to assist you via contact@gempex.com.
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