Chapter 4, Annex 11, Annex 22: Three Drafts, One Control System

One conference day in Shanghai, packed and inspiring in equal measure: a keynote and a panel at the Biopharmaceutical Bioprocess Development Summit, plus the deep-dive AI session at the AI for Pharma 2026 running in parallel. The question raised on…

The PIC/S Recommendation PI 006, Fourth Version: The Paradigm Shift in Qualification and Validation

PIC/S has rewritten its recommendations on qualification and validation: PI 006-4 replaces the 2007 version on October 1, 2026. The real change sits beneath the chapters: validation is no longer a completed event but a continuously demonstrated state. That is precisely…

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…

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…

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…

ISPE AI in Life Sciences Summit with QFINITY | June 22-23, 2026

QFINITY will be at the ISPE AI in Life Sciences Summit 2026 in Boston. The event takes place June 22-23 and brings together international experts in life sciences, validation, compliance, and digital innovation. The program focuses on current developments in…

ISPE Annual Meeting & Expo with QFINITY | October 18-21, 2026

We are glad to be at the 2026 ISPE Annual Meeting & Expo! It takes place October 18-21, 2026 at the Gaylord National Resort & Convention Center in National Harbor (Washington, D.C. metro area) – one of the central international…

30th GQMA Annual Conference with QFINITY | September 17-18, 2026

At the 30th GQMA Annual Conference, Frank Henrichmann (QFINITY) leads the workshop “AI in Computerized System Validation” – how AI, in particular large language models and generative AI-enabled tools, can be integrated across the entire CSV lifecycle, in line with…

48th GAMP D-A-CH Forum with QFINITY | September 9, 2026

We are glad to be at the 48th GAMP D-A-CH Forum! The forum of the ISPE D/A/CH GAMP Community of Practice takes place on September 9, 2026 at the NH Vienna Airport Conference Center in Schwechat near Vienna (SIG sessions…

19th Official GAMP 5 Conference with QFINITY | December 8-9, 2026

At the 19th Official GAMP 5 Conference in Mannheim (December 8-9, 2026), Oliver Herrmann contributes in three ways: as co-moderator of a panel on the future of CSV, in the ISPE/GAMP/VDI update, and with his own talk on progressive, verifiable…

3rd GAMP Conference: Artificial Intelligence Meets the Pharmaceutical Industry with QFINITY | December 10, 2026

At the 3rd GAMP Conference “Artificial Intelligence Meets Pharma” in Mannheim (December 10, 2026), Oliver Herrmann speaks on progressive QA in complex regulated environments – the architecture of computerized systems, the role of humans and the responsible use of AI.…

6th GAMP Conference GxP in the Cloud with QFINITY | December 10, 2026

QFINITY chairs the 6th GAMP Conference “GxP in the Cloud” in Mannheim (December 10, 2026): regulator, pharma QA and cloud providers at one table – with the guiding question of how control stays demonstrable when cloud, SaaS and AI change…