ISPE Annual Meeting | October 26-29, 2025

Event banner: ISPE Annual Meeting | October 26-29, 2025

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

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 (QFINITY), 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 for patient safety, data integrity, and product quality.

Beyond the expert input, the workshop makes room for discussion and knowledge-sharing with industry professionals, offering 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 (QFINITY), Frank Henrichmann (QFINITY)

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 it should not.

  • How control objectives and critical thinking can add value.

  • How to use standards and templates effectively without letting them become a burden.

With these two contributions, QFINITY adds its expertise in digital transformation, Pharma 4.0, and modern quality assurance to the international conversation.

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