QFINITY · Events · Meet QFINITY
Where you meet us in person.
An overview of the events QFINITY has taken part in or will be attending - conferences, talks and webinars. You'll often find us at ISPE and ACDM events. Stop by and talk to us in person.
Upcoming events
BPD Biopharmaceutical Bioprocess Development Summit with QFINITY | August 6-7, 2026
We are glad to be at the 9th BPD Biopharmaceutical Bioprocess Development Summit in Shanghai!
The summit runs August 6-7, 2026 in Shanghai – China’s benchmark event for biopharmaceutical process development, from research to commercial manufacturing. Since 2017 it has connected the entire CMC value chain; the 2025 edition drew more than 5,500 attendees and over 160 speakers. The AI FOR PHARMA Conference 2026 runs alongside it.
QFINITY on stage
Oliver Herrmann (QFINITY) and Martin Heitmann (MH Consulting & Advisory) are pleased to speak at both conferences on August 6: at the BPD Summit itself on the shift in EU GMP regulation, and at the parallel AI FOR PHARMA Conference on how adaptive AI only becomes GMP-ready under control.
Shifting the EU GMP Regulatory Paradigm – Annex 11 and Annex 22 Drafts
Oliver Herrmann (QFINITY) and Martin Heitmann (MH Consulting & Advisory)
“Global Expansion & Globalization” track. For companies expanding into European markets, the regulatory ground is shifting: the revised EU GMP Annex 11 and the new Annex 22 draft reshape how computerized systems – and, increasingly, AI – are assessed in GxP environments. The talk maps out what quality, IT, and regulatory teams need to prepare for.
Adaptive AI Without Control is Not GMP – From Potential to Controlled Biopharma
Digital Compliance Architecture for Trustworthy Adaptive AI-Enabled Systems from Process Development to GxP Manufacturing
Oliver Herrmann (QFINITY) and Martin Heitmann (MH Consulting & Advisory)
AI FOR PHARMA Conference. Adaptive AI systems change their behavior as new data comes in – exactly what makes them powerful and hard to keep in check. Without robust control, that potential never reaches GMP. The talk outlines a digital compliance architecture that keeps adaptive, AI-enabled systems trustworthy and verifiable, from process development through to GxP manufacturing.
Meet us in Shanghai – we look forward to connecting in person.
ISPE Pharma 4.0 & Biopharma Conference with QFINITY | December 10-11, 2026
We are pleased to be part of the 2026 ISPE Pharma 4.0 & Biopharma Conference!
The conference takes place on 10-11 December 2026 in Berlin – a central European meeting point for the digital transformation of the pharmaceutical industry. You can also attend virtually.
QFINITY on stage
In his talk, Oliver Herrmann shows how AI reshapes Quality Assurance in regulated environments – and why human oversight must be a designed structural element, not an end-of-line check.
Human Oversight by Design: Progressive QA for AI-Enabled GxP Systems
Oliver Herrmann (QFINITY)
AI does not just add tools to GxP. It changes how computerized systems behave. Execution moves from operation to supervision. Deterministic logic gives way to probabilistic output. This does not lower the demand for Quality Assurance. It raises it.
Quality no longer comes from validating a system in isolation. It emerges from the interaction of business processes, data, software, interfaces and decision structures. QA stops being a downstream control and becomes the architect of the landscape it once only inspected.
The GAMP AI Guide draws the distinction that carries this shift: the AI subsystem is not the computerized system, and the model is a component. What you validate is the system, against its intended use – not the model in the abstract. Human oversight is where this becomes concrete. Treated as a check at the end of the line, it controls nothing; designed into the architecture, it holds. Oversight is not a stage you add once the system runs – it is a property you build before it does.
AI runs on statistical inference. It produces plausibility, not understanding. Between a plausible output and a correct decision sits a structural gap. It does not close by trusting the model – it closes by design. Progressive QA is the answer to rising speed and complexity, managing the process, data and system layers at once. The core message: capability is not reliability – and the work of QA is to make that difference visible before the system does.
Program and registration at ISPE (ispe.org)↗
Attending in person? Reach out – we look forward to connecting.
Official GAMP 5 Basic Principles Training with QFINITY | October 22-23, 2026
Frank Henrichmann (QFINITY) will lead the official two-day GAMP 5 Basic Principles training in person at the ISPE Annual Meeting 2026 in National Harbor (Washington, D.C.) – a practical introduction to risk-based compliance for computerized systems based on the GAMP 5 Guide (Second Edition). October 22-23, 2026, Gaylord National Resort, National Harbor (Washington, D.C.), USA.
The official ISPE training course “Basic Principles of Computerized Systems Compliance” teaches the internationally recognized methods for ensuring that computerized systems in the pharmaceutical, biotech, and medical device industries comply with regulatory requirements and are “fit for intended use” – directly from the GAMP 5 Guide, Second Edition.
Contents
Format: 2-day in-person course (8:30 a.m.-4:30 p.m. EDT), Fundamental level, language: English, 1.3 ISPE CEUs. Trainer: Frank Henrichmann, Senior Executive Consultant at QFINITY and Chair of the Global GAMP Steering Committee. The training immediately follows the ISPE Annual Meeting & Expo (October 18-21).
Course details and registration via ISPE (ispe.org)↗