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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.
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April 19-21, 2023 | European QA Conference
Frank Henrichmann and Oliver Herrmann from QFINITY will be at the European QA Conference in Mainz.
The program includes a wide range of sessions with outstanding and professional speakers. Between presentations, you will have the chance to connect with both familiar faces and newcomers during the breaks and at the conference reception on Wednesday.
Our CEO Oliver Herrmann and Sr. Executive Consultant Frank Henrichmann will give an introduction to the new ISPE GAMP 5 (Second Edition).
The talk will give an overview of:
– Changes and Updates in GAMP 5 (Second Edition)
– the role of critical thinking in validation
– Risk Assessment and Computer Software Assurance
April 18, 2023 | Lounges in Karlsruhe
Oliver Herrmann (CEO and founder of QFINITY) and Frank Henrichmann (Senior Executive Consultant at QFINITY) will give two presentations at the Lounges in Karlsruhe.
Oliver Herrmann will give a presentation titled GAMP®5 – 2nd Edition – Applying the Key Principles to enable Innovation
The presentation will provide an introduction to the key principles of GAMP 5 Second Edition and how they apply in an ever-changing world. It will also briefly introduce the new GAMP Guides. Key challenges arise in the areas of Critical Thinking/CSA/RBA, AI, Agile and IS (Cloud) Management. The presentation will also give an overview and share first practical experiences of applying these special topics and implementing them in projects in an integrated way.
Frank Henrichmann will give a presentation titled GAMP 5 Second Edition – Specifying Requirements
The presentation will provide an introduction to GAMP 5 Second Edition in general and then explore Requirements Management. After all, GAMP is embracing agile methodologies and the traditional separation into User Requirements, Functional requirements and other requirements is no longer present in the guide. However, some things did not change. Bad Requirements are still bad, whether expressed as user stories in a system or in a specification document. And bad requirements inevitably lead to systems that are not fit for purpose and do not meet regulatory expectations.
March 12-13, 2023 | ACDM Annual Conference
Marcus Schwabedissen, an active member of ACDM, and Frank Henrichmann, Senior Executive Consultant at QFINITY and member of the GAMP Global Steering Committee, will be attending this year’s ACDM conference in Barcelona.
Frank Henrichmann will give a talk offering a pragmatic, forward-looking overview of how to identify and avoid bias in machine learning solutions. Numerous ML systems have failed to produce acceptable results because the model or training data were biased. Frank’s presentation will explore past mistakes, their consequences, and possible strategies for identifying and avoiding bias. He will analyze examples from healthcare and other industries and identify what caused the bias in each system. Based on these insights, the audience will learn how bias can find its way into their systems. The talk offers practical guidance on identifying sources of bias and avoiding it in ML systems.