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.

Oliver Herrmann and Frank Henrichmann from QFINITY will be present at this year’s ISPE Europe Annual Conference.

Frank Henrichmann organizes and moderates the GAMP 5 track at the ISPE EU Annual Meeting.

Oliver Herrmann will lead a workshop there together with Elena Vulpe on the topic of GAMP 5 Second Edition – Data Integrity/Computer Software Assurance (CSA). In this interactive workshop, practice examples will be discussed and analyzed together with the developers of the CSA guidelines and practitioners from the EU and the US. Oliver and Elena will be supported by Ken Shitamoto, Ray Murphy and Khaled Moussally from the FISCA team.

More information and details about the process can be found on the ISPE website.

https://ispe.org/conferences/2023-europe-annual-conference/programme

Oliver Herrmann (CEO and founder of QFINITY) and Frank Henrichmann (Senior Executive Consultant at QFINITY) will give two presentations at the Lounges in Karlsruhe.

Oliver Herrmann will give a presentation on the topic GAMP®5 – 2nd Edition – Applying the Key Principles to enable Innovation

The presentation will provide an introduction to the key principles of GAMP 5 Second Edition and how they apply in an ever-changing world In addition, the new GAMP Guides will be briefly introduced. Key challenges arise in the areas of Critical Thinking/CSA/RBA, AI, Agile and IS (Cloud) Management. In addition, the presentation will give an overview and first practical experiences in the application of these special topics as well as their integrated implementation in projects.

Frank Henrichmann will give a presentation about the topic GAMP 5 Second Edition – Specifying Requirements

The presentation will provide an introduction to GAMP 5 Second Edition in general and then explore Requirements Management. After all, GAMP is embracing agile methodologies and the traditional separation into User Requirements, Functional requirements and other requirements is no longer present in the guide. However, some things did not change. Bad Requirements are still bad, whether expressed as user stories in a system or in a specification document. And bad requirements are inevitably lead to systems that are not fit for purpoase and not meeting regulatory expectations.