QFINITY´s CEO Oliver Herrmann, COO Marcus Schwabedissen and Sr. Executive Consultant Frank Henrichmann were at the 16th GAMP D-A-CH Conference.

Report 16th GAMP D-A-CH Conference

Innovation, Digital Transformation and GxP

Our CEO Oliver Herrmann and Bernhard Appel were leading a discussion round on the topic “Innovation, Digital Transformation and GxP – now more than ever!”. In their discussion their mentioned that in today’s world, companies are faced with the challenge of driving innovation and digitalization. At the same time their having to adhere to strict regulations and compliance requirements. The discussion centres on the possibility of combining innovation and compliance. It is emphasised that it is entirely possible to achieve both without jeopardising patient safety and product quality. Quality Management & Compliance plays a crucial role in this, as it ensures that processes run at the highest level without compromising on safety.

Report 16th GAMP D-A-CH ConferenceAspects of recovering from a disaster

Frank Henrichmann presented on Dec. 7th, 2023, as part of the 3. GAMP® Konferenz GxP in der Cloud in Mannheim, on practical aspects of recovering from a disaster. This is a hot topic as current data clearly demonstrate that it is only a question of time till 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. It was shown that good planning before the attack happens is key to a successful und timely recovery. But even the best plans need to be adapted and adjusted to the actual scenario when the disaster happens. He focused on the challenges and questions that quality functions need to address and support to ensure the validation state of the applications and the integrity of the recovered data in the pharmaceutical industry.

Sustainability and GxP

The panel discussion on “Sustainability and GxP” was moderated by Marcus Schwabedissen (QFINITY) and Steffen Ruttscheidt (d-fine GmbH). It provided an insight into the growing importance of sustainability in the context of the life science industry (GxP). It also showed its impact on the industry. In their presentation they showed that the Corporate Sustainability Reporting Directive (CSRD) plays a crucial role in this context. CSRD will oblige companies to produce more detailed sustainability reports. This will promote better transparency and accountability in terms of environmental impact and social responsibility. This will also affect companies in GxP-regulated industries, as they will also have to implement sustainable practices.

QFINITY is proud to have participated in this year’s GAMP Conference. Further information about the conference can be found at ISPE. For more information on events with QFINITY, please visit our website.

A few months ago, our CEO has already travelled to China to give various training sessions and presentations.

Trainings in ChinaNow, some weeks ago, QFINITY’s Senior Executive Consultant Frank Henrichmann conducted several CSV Trainings 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 be used to 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.

Marcus Schwabedissen (COO at QFINITY) has been an active member of ACDM for many years and is particularly involved in the field of artificial intelligence. At the recent ACDM: Association for Clinical Data Management Annual Symposium on Artificial Intelligence in Clinical Trials, the speakers andTopic AI participants, including Marcus Schwabedissen, were asked for their personal opinion on the topic of AI.

In this video, you can hear Marcus Schwabedissen’s opinion on how artificial intelligence can help in all areas of the value chain.

Watch the video here.Following the success of the AI Symposium, the ACDM community will meet again in London on 24 November. The discussion on risk-based quality management will continue on site. QFNITY is looking forward to being a part of it.

If you have any questions on the Topic AI, you can reach us at any time via our contact form.

Oliver Herrmann gave a two-day GAMP 5 basic training in Las Vegas in the context of the ISPE Annual Meeting. He was able to convey to his attentive audience the basics and principles of computer system validation as described in GAMP 5 Second Edition. Oliver Herrmann, one of the two certified ISPE trainers for GAMP in Germany, was supported ion site by Brandon Pastore.GAMP 5 basic training

For more information on the GAMP 5 basic training, click here.

The newly appointed Co-Chair of the ISPE GAMP Global Steering Committee, QFINITY’s Frank Henrichmann, has been interviewed by the ISPE during the ISPE Annual Meeting 2023 in Las Vegas. During the interview he shared his personal experience and journey within ISPE, how it helped him in his career and development and the value of attending ISPE Meetings and volunteering.Interview with QFINITY by the ISPE

Here you can find more Information about QFINITY´s News and Events with QFINITY in the near future. If you have any questions feel free to contact us via our contact formular.

If you want more information about the Interview and the ISPE have a look on their Webpage.

Frank Henrichmann, Sr. Exec. Consultant at QFINITY has taken on his new role as Co-Chair ofCo-Chair of the ISPE GAMP Global Steering Committee the ISPE GAMP Global Steering Committee as of Oct. 18th, 2023. Together with the Chair Charlie Wakeham, he will lead the GAMP Community of Practice within ISPE. This organization produces and publishes the GAMP guides, which are considered the gold standard for computerized system validation within the industry.

We are excited and proud that Frank has been elected for this position.

For more information about QFINITY check our News Page or contact us via our contact formular.

Here you can find more information about the ISPE and the Co-Chair.

 

Marcus Schwabedissen (COO and Senior Executive Consultant at QFINITY) represented us at this year’s GAMP UK Forum.

On site, he led a roundtable discussion on the topic of clinical systems. The strong interest of the community was evident from the high turnout and intense discussion.GAMP UK

It was a great pleasure to be represented at the GAMP UK Forum.

If you would like information on other events by and with QFINITY, click here.

You can find more events on GAMP at ISPE.

If you need advice on any of our topics, please feel free to contact us via our contact form. We look forward to hearing from you soon.

After the success of the ACDM AI Symposium last year, the ACDM organised a second AI Symposium on 20-21 September.

Last year, Marcus Schwabedissen (COO and Senior Executive Consultant at QFINITY) gave a presentation. This year, however, he helped with the planning and preparation as a member of the Steering Committee.AI Symposium ACDM

The event was very well attended and had a broad programme of presentations, field reports and discussions.

Lifesciences, service providers and solution providers were represented, so that excellent networking could take place.

Following this success, a third Symposium is already being planned for 2024.

For information on other events with and by QFINITY, click here.

For more events from the ACDM, click here.

On September 21, the ACDM Symposium for Artificial Intelligence will take place in Copenhagen. The event has been planned, long in the making, by the Steering Group. The Steering Group consists of Richard Davies, Ashley Howard, Tim Armitage and QFINITY’s COO Marcus Schwabedissen.

For the event, the Steering Group planned the entire program in detail. The event on artificial intelligence will explain the different types of artificial intelligence as well as the applications of them. Practical examples of these techniques will be discussed using clinical trials.

Marcus Schwabedissen has been a very active member of ACDM for many years. His core topic in the organization is artificial intelligence. He is concerned with how to apply it, improve it and use it optimally for business processes.

QFINITY is proud that Marcus Schwabedissen is part of the Steering Group and helps significantly to the planning of the event with his expertise in AI.

Artificial Intelligence is a constantly evolving topic that is indispensable nowadays. It facilitates work processes and increases their efficiency. QFINITY is one of the leading consulting companies in the field of AI. If you are interested, we will be happy to advise our clients in this area and help you implement, apply and optimize AI in your company.

You need advice on artificial intelligence? Please contact us here!

If you would like to learn more about ACDM and the symposium on AI, click here!

Oliver Herrmann (CEO of QFINITY) and Frank Henrichmann (Sr. Executive Consultant at QFINTIY) have been members of the global ISPE GAMP Steering Committee for several years.

Now both have received the Committee of the Year award from ISPE.
The ISPE GAMP Community of Practice received this award at the 2022 ISPE Annual Meeting & Expo in Orlando for creating GAMP 5 Second Edition.

Both have deserved this award. Congratulations!

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