AI in GxP Auditing: From Hype to Validated Practice
Artificial Intelligence is rapidly transforming pharmaceutical quality—but how can organizations harness its potential while remaining fully compliant in GxP environments?
Join the first session of the ISPE Netherlands Quality Community of Practice – Expert Quality Dialogue Lunch Series, delivered in collaboration with The QARP Academy. This interactive dialogue brings together the perspectives of pharmaceutical manufacturing and GxP auditing to explore how AI can be implemented responsibly, effectively, and in a way that withstands regulatory scrutiny.
Unlike traditional webinars, this expert dialogue combines practical experience, regulatory expectations, and audience interaction.
Duration: 75 minutes (45 minutes content + 30 minutes discussion)
Attendence: Free for ISPE members - Paid for non-members (60 euro)
More information and registration (from 01 October 2026) via this link: https://theqarpacademy.pro/courses/c9fa407c-645b-4efa-9105-ea65b23aa604
Event Properties
| Event Date | 30-Oct-2026 12:00 - 13:15 |
| Capacity | Unlimited |
| Registered | 0 |
| Individual Price | free for ISPE members |
Speakers
Maxim Bunimovich
MD, MRQA, MSQA
Founder & CEO, The QARP | Lead GxP Auditor Maxim Bunimovich is an international GxP Quality leader, auditor, trainer, and Founder & CEO of The QARP. He specializes in building practical, inspection-ready quality systems that connect regulatory expectations, operational reality, technology, and people across the life sciences industry. Drawing on extensive experience in GCP, GMP, vendor oversight, computerized-system validation, and inspection readiness, Maxim helps organizations strengthen quality culture, manage risk, and translate complex regulatory requirements into sustainable day-to-day practice. His work positions Quality not merely as a compliance function, but as a strategic partner that enables trust, informed decision-making, operational resilience, and responsible innovation. Maxim has a particular focus on the responsible adoption of AI in GxP-regulated environments. He supports organizations in establishing the evidence, validation, governance, data integrity controls, and human oversight needed to use AI with confidence while maintaining accountability and regulatory compliance. He believes that effective quality is not created through procedures alone—it is built through competent people, clear leadership, sound judgment, and systems that work in practice. In this dialogue, Maxim will bring the auditor’s perspective on what inspectors expect when AI supports quality decisions, and how organizations can demonstrate that innovation remains controlled, transparent, and inspection-ready.
Natalia Vtyurina
PhD, sMBA
Founder & Chair, ISPE Netherlands Quality Community of Practice Natalia Vtyurina is a Quality leader specializing in Quality 5.0, quality culture, AI governance, knowledge management, and human-centric digital transformation in the life sciences industry. As Founder and Chair of the ISPE Netherlands Quality Community of Practice, she brings together professionals to exchange knowledge, strengthen collaboration, and accelerate innovation across the sector. Drawing on her experience in pharmaceutical manufacturing and GxP Quality, she helps organizations position Quality as a strategic business partner that connects people, technology, knowledge, and business. Her work focuses on enabling responsible AI adoption while preserving human judgment, trust, accountability, and regulatory compliance. Natalia believes that technology doesn't transform organizations—people, culture, and leadership do.