The German Management Quality Association was founded in 1995 and now has over 900 members. Their members work in various branches of industry, contract institutes, clinical laboratories and departments as well as industrial laboratories, clinics and public authorities. The main objectives of the GQMA are to promote the exchange of scientific information and opinions and to promote education and training for specific purposes.

QFINITY’s Senior Executive Consultant Dr. Jenny Gebhardt will present the brand new second edition of the ISPE GAMP Good eClinical Practice Guide at the 28th Annual Meeting of the German Management Quality Association .

The annual meeting will take place on September 19-20, 2024 in Neuss, Germany.

Further information about the GQMA can be found here.

Further information on the ISPE GAMP Good Practice Guide for eClinical Systems can be found here.

The CEO of QFINITY, Oliver Herrmann, will take part in Achema 2024 – World Forum and 34th Leading International Trade Fair for the Process Industries.

The event for chemical and pharmaceutical technology, biological technology and industrial environmental technologies will take place from June 10 – 14 in Frankfurt am Main. This year the event will focus on the six innovation themes: Digital, Green, Lab, Pharma, Process and Hydrogen.

Mr. Herrmann will give a presentation and participate in the panel discussion.

QFINITY is honored to participate in Achema 2024 and is looking forward to the event.

Further information about this event can be found here. Further events with QFINITY can be found here.

Marcus Schwabedissen, COO, and Frank Henrichmann, Senior Executive Consultant, from QFINITY will be at the ACDM Annual Meeting in Copenhagen. This Meeting will take place from 3rd– to 5th March.

We are very pleased that Frank Henrichmann will present on that conference on the topic of “How to comply with EU Guideline on computerised systems and electronic data in clinical trials”. This regulatory guideline was released by the EMA in 2023. It is the most extensive and detailed guidance ever published specifically for GCP systems. The EMA guideline covers key definitions and principles like Source Data, Responsibilities, and Data Integrity, expectations on Computerized systems, and their validation, including vendor management. Electronic data, from capturing data to Audit trail review and migration, are covered along with security expectations.

His presentation will focus on the key topics addressed in that guideline and challenges in the adoption of it.

What were the reasons and intentions of the regulators when creating this guidance?

What are the most critical changes, and how can we address them?

The key focus of the presentation will be the validation of computerised systems used within clinical trials at clinical sites. He will also talk about the expectations on vendor oversight and collaboration especially in the usage of Software-as-a-Service (SaaS) and the detailed expectations on data archiving and retention.

We are looking forward to meeting you there and to discuss technology quality management topics with you.

For more information about the ACDM Annual Meeting click here.

On 2/3 November, Frank Henrichmann, together with Global GAMP Steering Committee members Heather Watson (TenTenTen) and Thanabalan Subramanian (Integrity), will present GAMP 5 Second Edition at the ISPE India Manufacturing , Quality & Compliance Conference 2023 in Hyderabad. The programme will cover a wide range of sessions topics e.g. Annex 1, Quality & Compliance, Computerized Systems, Innovations in Technology and much more. We are looking forward to the event and the exchange with our colleagues in India.

For more information on the ISPE India Manufacturing, Quality & Compliance Conference, click here.

Further events with and from QFINITY can be found here.

We are looking forward to meeting you on site.