GAMP Community of Practice - Update
ISPE - International Society for Pharmaceutical Engineering D/A/CH e.V. · Oliver Herrmann
25/03/2025, 11:00 · Room 6 · DE
I. GAMP Community of Practice - Update
II. Smart Validation through the Skillful Integration of Risk & Knowledge Management
- How can QA be skillfully aligned to effectively manage knowledge and risks, ensure compliance, and maintain quality?
- How can the documentation burden be reduced to achieve efficient and streamlined validation without bureaucratic obstacles?
- How does a risk-based, knowledge-driven approach replace rigid requirements and enable more flexible, digital validation?
- How can validation become more agile and scalable to reduce complexity and maintain compliance efficiently?
- How can system quality and compliance be ensured without unnecessary processes and additional effort?Agenda
- Wie kann QA strategisch ausgerichtet?
- Wie lässt sich die Dokumentenflut reduzieren?
- Wie kann Validierung agiler / skalierbarer gestaltet werden?
- Wie kann die Systemqualität sichergestellt werden?