QFINITY · News · Insights & Events
Shaping the regulated quality of tomorrow.
Articles and analysis from our own work across GxP, pharma, quality management, GAMP and AI - what is changing in the regulated environment, what it means in practice, and what is happening inside our company.
Latest articles
Report 16th GAMP D-A-CH Conference
At the 16th GAMP D-A-CH conference, QFINITY was represented by CEO Oliver Herrmann, COO Marcus Schwabedissen, and Sr. Executive Consultant Frank Henrichmann – with a panel on innovation, digital transformation, and GxP, plus a talk on recovery after a cyber disaster.
QFINITY’s CEO Oliver Herrmann, COO Marcus Schwabedissen, and Sr. Executive Consultant Frank Henrichmann were at the 16th GAMP D-A-CH Conference.
Innovation, Digital Transformation and GxP
Our CEO Oliver Herrmann and Bernhard Appel led a panel discussion on “Innovation, Digital Transformation and GxP – now more than ever!”. They noted that companies today face the challenge of driving innovation and digitalization while also having to adhere to strict regulations and compliance requirements. The discussion centered on whether innovation and compliance can be combined. They emphasized that it is entirely possible to achieve both without jeopardizing patient safety or product quality. Quality Management & Compliance plays a crucial role here, as it ensures that processes run at the highest level without compromising safety.
On Dec. 7th, 2023, at the 3. GAMP Konferenz GxP in der Cloud in Mannheim, Frank Henrichmann presented practical aspects of recovering from a disaster. This is a hot topic: current data clearly show it is only a matter of time until a company is hit by a cyberattack. He used a ransomware attack on a cloud service provider as a hypothetical case study to highlight the potential challenges in the recovery process. He showed that good planning before the attack happens is key to a successful and timely recovery. But even the best plans need to be adapted to the actual scenario once disaster strikes. He focused on the challenges and questions that quality functions need to address and support to ensure the validated state of the applications and the integrity of the recovered data in the pharmaceutical industry.
Sustainability and GxP
Marcus Schwabedissen (QFINITY) and Steffen Ruttscheidt (d-fine GmbH) moderated the panel discussion on “Sustainability and GxP”. It offered insight into the growing importance of sustainability in the life science industry (GxP) and its impact on the sector. They showed that the Corporate Sustainability Reporting Directive (CSRD) plays a crucial role here. The CSRD will require companies to produce more detailed sustainability reports, promoting greater transparency and accountability around environmental impact and social responsibility. Companies in GxP-regulated industries will feel this too, as they will also have to implement sustainable practices.
QFINITY is proud to have participated in this year’s GAMP Conference. You can find further information about the conference at ISPE. For more information on events with QFINITY, please visit our website.
QFINITY Team Members gave Trainings in China
A few months ago, our CEO traveled to China to give various training sessions and presentations.
A few weeks ago, QFINITY’s Senior Executive Consultant Frank Henrichmann conducted several CSV training sessions in China in collaboration with our partner AUSTAR. During his two-week trip, he visited several cities and companies to provide an overview of the regulatory expectations and how guidelines like GAMP 5 can help fulfill them. In Question & Answer sessions, he addressed customer-specific concerns and issues related to Infrastructure Qualification, Data Integrity, System Life Cycle, Test approaches and other aspects of Computerized System Validation.
For more information about QFINITY and our news, have a look at our website.
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.