QFINITY · Updates
The latest from QFINITY and the field.
An overview of updates beyond events and projects: articles and publications, work in industry bodies and committees, awards, and our perspective on new regulations.
At a glance
An overview of updates beyond events and projects: articles and publications, work in industry bodies and committees, awards, and our perspective on new regulations.
Frank Henrichmann Appointed Chair of the ISPE GAMP Global Steering Committee
QFINITY is pleased to announce that Frank Henrichmann, Senior Executive Consultant at QFINITY, has been appointed Chair of the ISPE GAMP Global Steering Committee. In this role, he succeeds Charlie Wakeham, whose exceptional commitment and inspiring leadership have significantly shaped the work of the GAMP network in recent years.
We sincerely thank Charlie for her vision and tireless dedication and are delighted that she will continue to serve on the Leadership Team as Past Chair.
Together with Co-Chair Thana Subramanian and Secretary Brandi Stockton, Frank Henrichmann will drive GAMP’s strategic direction and continued development. The mission of the GAMP Global Steering Committee is to foster innovation, digital transformation, and quality within the life sciences industry.
QFINITY is proud of Frank’s active engagement within the global ISPE community and congratulates him warmly on his appointment as Chair.
For more information about ISPE, please visit ISPE’s website.
QFINITY as training lead by the KKS Network
We were pleased to take on the training lead and moderation of an internal workshop organized by the KKS Network Fulda on “Auditing IT Vendors.”
Audits are a key component of quality assurance in clinical trials – especially when external service providers (vendors) are involved. IT vendor audits are becoming increasingly important for minimizing risks to sponsors and investigational sites while ensuring compliance with legal and regulatory requirements.
Together with auditors and experts from IT, project management, and quality management, we delivered practical, hands-on training. Topics included regulatory fundamentals, compliance with GCP guidelines, and the preparation, execution, and structured follow-up of audits involving IT service providers.
Through interactive group work – for example, on an EDC (Electronic Data Capture) system provider – participants were able to actively explore and reflect on the interplay between theory and practice.
Our conclusion:
The interdisciplinary exchange showed how crucial a shared understanding between IT, quality assurance, and operational units is for designing audit processes that are both effective and sustainable.
We thank the KKS Network for their trust and the successful collaboration. We look forward to continuing to help strengthen quality and compliance in clinical research.
For more information about the training and QFINITY’s role as training lead, please visit the KKS Network on LinkedIn.
Nomination for the Roger F. Sherwood Award
We are very pleased that a QFINITY article has been nominated as a finalist for the 2024 Roger F. Sherwood Award.
The article is titled “Quality Considerations in Disaster Recovery: A Case Study.”
It was published in the January/February 2024 issue of the renowned journal Pharmaceutical Engineering. The article stands out for its thorough treatment of quality considerations in disaster recovery and has resonated strongly with readers. With this nomination, the ISPE (International Society for Pharmaceutical Engineering) recognizes the article’s quality and its relevance to the pharmaceutical industry.
The Roger F. Sherwood Award has been presented annually since 1993 and honors the best technical contributions published in Pharmaceutical Engineering. The award aims to highlight outstanding content, promote knowledge sharing within the industry, and underscore ISPE’s role as a global knowledge leader.
The winning article will be announced during the ISPE Annual Meeting & Expo 2025, taking place on 28 October in Charlotte, North Carolina.
At QFINITY, we are proud of this nomination and sincerely thank ISPE for recognizing our work. It motivates us to keep sharing our expertise with the industry.
You can find more information about the award on the ISPE website.
Explore more publications from QFINITY.
Read the article at Pharmaceutical Engineering (ispe.org)↗