QFINITY · Events · Meet QFINITY
Where you meet us in person.
An overview of the events QFINITY takes part in or has attended, from conferences and talks to webinars. These include our own workshops as well as reports from events of ISPE, ACDM and other associations. Stop by and talk to us in person.
Latest events
ACDM Annual Meeting | March 3-5, 2024
Marcus Schwabedissen, COO, and Frank Henrichmann, Senior Executive Consultant, from QFINITY will be at the ACDM Annual Meeting in Copenhagen from March 3rd to 5th.
We are very pleased that Frank Henrichmann will present “How to comply with EU Guideline on computerised systems and electronic data in clinical trials” at the conference. The EMA released this regulatory guideline 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, along with expectations for computerized systems and their validation, including vendor management. It also covers electronic data – from data capture to audit trail review and migration – together with security expectations.
His presentation will focus on the guideline’s key topics and the challenges of adopting it.
What were the regulators’ reasons and intentions in creating this guidance?
What are the most critical changes, and how can we address them?
The main focus will be the validation of computerized systems used in clinical trials at clinical sites. He will also cover expectations for vendor oversight and collaboration, especially when using Software-as-a-Service (SaaS), and the detailed expectations for data archiving and retention.
We look forward to meeting you there and discussing technology quality management topics with you.
For more information about the ACDM Annual Meeting, click here.
16th GAMP Conference | December 5-7, 2023
As in previous years, we are pleased that QFINITY will attend the GAMP conference in Mannheim. The 16th GAMP conference will take place from 5 to 7 December and promises to be another outstanding platform for sharing knowledge and discussing current topics. In his presentation on Thursday, 7 December, Frank Henrichmann will take an in-depth look at “Practical aspects of post-disaster recovery”.
QFINITY is honored and highly motivated to take part in the 16th GAMP conference. We look forward to lively discussions with colleagues, experts, and anyone interested.
You can find more information about the 16th GAMP conference at the following link: https://www.gamp-dach.de/. We invite you to take a look at the program and the registration details.
We would be delighted to meet you in person at the conference.
You can find out more about upcoming events organized or supported by QFINITY on our website.
If you have any questions, feel free to reach out anytime via our contact form. We are happy to help.
We look forward to the GAMP conference – and to talking with you there.
ISPE India Manufacturing, Quality & Compliance Conference | November 2-3, 2023
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 program covers a wide range of session topics, including Annex 1, Quality & Compliance, Computerized Systems, Innovations in Technology, and much more. We look forward to the event and to exchanging ideas with our colleagues in India.
For more information on the ISPE India Manufacturing, Quality & Compliance Conference, click here.
You can find more events with QFINITY here.
We look forward to meeting you on site.