ISPE Annual Meeting | 26.-29. October 2025

ISPE Annual Meeting 2025This year again, QFINITY will be represented at the ISPE Annual Meeting & Expo 2025, actively contributing to the program with two expert sessions.

The event will take place from October 26–29, 2025, in Charlotte, NC.

Workshop: Implementing an AI Solution in a Pharma 4.0 Context
📅 Sunday, October 26, 2025 | 1:00 – 4:00 pm
👥 Speakers: Martin Heitmann (The Triality Group, LLC), Frank Henrichmann (Q-FINITY Quality Management), Brandi Stockton (The Triality Group, LLC), Paige Kane (CAI)

In this interactive workshop, participants will learn hands-on methods for implementing and validating AI/ML solutions in GxP-regulated environments. Key topics include:

  • Maturity assessments for evaluating the digital readiness of organizations.

  • Risk assessment of AI systems with regard to patient safety, data integrity, and product quality.

In addition to expert input, the workshop offers space for discussion and knowledge-sharing with industry professionals, providing valuable insights into the validation challenges of digital transformation.

Presentation: Future-Proof QA – From Documentation to Control Objective
📅 Tuesday, October 28, 2025 | 10:30 – 11:00 am
👥 Speakers: Oliver Herrmann (Q-FINITY Quality Management), Frank Henrichmann (Q-FINITY Quality Management)

The role of Quality Assurance in IT validation projects is changing: moving away from paper-heavy documentation toward risk-based, system- and data-focused approaches.

This presentation highlights how to build a future-oriented QMS for CSV that combines flexibility and compliance. Key aspects include:

  • What skills QA needs to effectively support projects.

  • Which content QA should review—and which not.

  • How control objectives and critical thinking can create added value.

  • How to use standards and templates effectively without becoming a burden.

With these two contributions, QFINITY brings its expertise in digital transformation, Pharma 4.0, and modern quality assurance into the international discussion.

👉 We look forward to engaging with you in Charlotte! For more information about the ISPE Annual Meeting 2025, please visit ISPE.