ACHEMA is a world forum for the process industry. Manufacturers and service providers from over 50 countries present products for the chemical, pharmaceutical, biotechnology, energy and environmental sectors. Presentations are also given on various topics.Presentation ACHEMA

Once again this year, a large number of experts gave presentations on a wide variety of topics. The topics ranged from the latest trends in pharmaceutical technology to innovative solutions for industry.

Our CEO Oliver Herrmann gave a presentation on the ZETA Pharma Innovation Stage together with Martin Heitmann. The presentation entitled: “From regulatory perspective to operational AI: Unlocking new digital horizons by applying GAMP” was a success and was discussed in greater depth in a panel discussion.

Further information on ACHEMA 2024 can be found here.

Our CEO Oliver Herrmann was at the 30th anniversary of ISPE D/A/CH.

30th anniversary of ISPE D/A/CHA total of 165 registered members celebrated the 30th anniversary of ISPE D/A/CH last week at the Annual General Meeting in Leverkusen. The motto of the event was “Shape the pharma world of tomorrow” and participants were treated to a two-day program full of expert presentations on current trend topics.

Oliver Herrmann also gave a presentation at the event.

We are delighted that Oliver Herrmann was able to take part in this event.

You can find more impressions of the event here.

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QFINITY’s CEO Oliver Herrmann, COO Marcus Schwabedissen and Sr. Exc. Consultant Frank Henrichmann have published an article in the official ISPE magazine.Artikel im ISPE Magazin

Due to the increasing digitalization of the industry, we are highly dependent on IT systems and data. Attacks on cyber security have been on the rise for many years. Ransomware and phishing are the biggest threats to our industry. Unfortunately, people tend to think that disasters “only happen to other people”. As a result, they don’t pay enough attention to disaster recovery and business continuity planning. When an organization is hit by a ransomware attack, the value of pre-planning and preparation becomes clear and allows for efficient recovery.

The article examines a hypothetical case of a successful ransomware attack. It outlines what recovery activities are required. The article also highlights the problems that arise from inadequate disaster recovery planning. It also examines the potential challenges for the quality organization, such as root cause analysis and documentation of recovery activities, risk management and assessment of data integrity during recovery activities or the evaluation of short-term workarounds.

We are pleased to have published another article in the official ISPE magazine in the form of this article.

You can find the article at ISPE.

Further news from QFINITY can be found under News.

 

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.