Good Working Practices (GWP). Without Silos: Quality, Culture & Integration
Date: 9 June 2026 | 13:00–19:00
Location: BioTech Training Facility (BTF), Sylviusweg 70, Leiden Bio Science Park, the Netherlands
On 9 June 2026, the ISPE NL Quality Community of Practice invites you to an interactive seminar focused on bringing SMEs, QA/QP professionals, and Senior Management closer together around one shared objective: delivering safe, high-quality products to patients.
Automation, AI, and data-driven quality systems are transforming pharma — bringing efficiency, but also increasing complexity and adoption challenges. True excellence in implementing these innovations is achieved when process, performance, and people move in the same direction.
Quality acts as the connector between technical expertise, operational execution, regulatory requirements, and strategic leadership, providing a shared language to bridge silos, strengthen collaboration, and drive performance, innovation, and trust.
This seminar explores how to move beyond compliance and beyond silos, toward a fully integrated and human-centric Quality approach (Quality 5.0) — where Quality is embedded across all functions and decision-making processes.
The program is built around an integrated Quality approach:
Risk Management → Process Management → Knowledge Management → State of Control
This approach enables predictive quality, better decision-making, and sustainable organizational maturity.
Participants will explore how these elements support predictive quality, improved collaboration, and stronger organizational maturity.
Key themes include:
- Drive the shift toward human-centric, integrated Quality (Quality 5.0)
- Design systems where doing the right thing is the easiest thing
- Integrate KM & QRM to enable continuous improvement
- Turn PQR and monitoring into strategic insights
- Strengthen cross-functional collaboration and trust
- Move from compliance-driven to performance-driven Quality
This seminar combines expert insights with interactive discussion, allowing participants to exchange perspectives across roles and organizations. By connecting culture, systems, and behavior, the event provides a practical foundation for implementing Good Working Practices (GWP) in modern pharmaceutical environment.
Event Properties
| Event Date | 09-Jun-2026 12.00 |
| Event End Date | 09-Jun-2026 19.00 |
| Capacity | 50 |
| Registered | 18 |
| Individual Price | 50 EUR. Free for ISPE members |
| Location | Biotech Training Facility |
Agendas
| 12:00 |
Lunch |
| 13:00 |
Opening ISPE & BTF & MediaVision |
| 13:15 |
Paradigm Shift: First Steps Toward Quality integrationKey Note: Natalia Vtyurina |
| 14:00 |
Coffee BreakBreak with questions about culture |
| 14:20 |
Make Quality Easy: Following the Path of Least ResistanceAli Amghar |
| 14:55 |
Enabling Continuous Improvement by integration of Knowledge and Risk ManagementManouk Tchkrtchian |
| 15:30 |
Interactive part: break outs with target groupsPractical session with actual quesitions between SMEs, QA/QP professionals and Senior Management |
| 16:15 |
Evaluation & Closure |
| 16:30 |
BTF Facility Tour |
| 17:00 |
Networking Drinks |
Speakers
Natalia Vtyurina
“More data requires more critical thinking — not less”
The pharmaceutical industry is undergoing rapid digital transformation driven by automation and data-driven quality systems, which, while increasing efficiency and control, can also introduce uncertainty and resistance if not implemented thoughtfully. This session explores the transition from Quality 4.0 to Quality 5.0, where digitalisation evolves into a human-centric, ethical, and sustainable quality ecosystem — and where Quality becomes a deeply integrated discipline across all departments, breaking down silos. Organizations must move beyond short-term responses and create space for integrated decision-making environments where HR, QA, leadership, and employee representation collaborate transparently. This enables the implementation of strategic, innovative manufacturing solutions that form a strong foundation for continuous, long-term improvement.
Ali Amghar
“Make the easy thing the right thing.”
Understanding quality is one thing. Making it easy to do the right thing is another. In this talk, we explore a deceptively simple idea: if the right action is also the easiest action, quality stops being a discipline and becomes an outcome. We examine how QA professionals can shape environments, processes, and systems so that stakeholders don't need to think about quality; they simply do it. Because the most powerful quality system isn't the one with the most controls. It's the one where doing the right thing requires no effort at all.
Manouk Tchkrtchian
“Capture knowledge today, or risk losing it tomorrow.”
Enabling Continuous Improvement by integration of Knowledge and Risk Management Quote: “Capture knowledge today, or risk losing it tomorrow.” Unlock the full potential of your pharmaceutical quality system by integrating Knowledge Management (KM) and Quality Risk Management (QRM) as enablers of continuous improvement. Anchored in the Risk–Knowledge Infinity (RKI) Cycle, this session shows how risk-based decisions generate and strengthen product and process knowledge. Discover how Product Quality Review (PQR) and ongoing process verification can evolve into powerful sources of insight instead of just administration. Elevate quality from compliance to a strategic driver of performance.
