Trial Master File and Inspection Readiness Conference
George Noşca
Associate Director, GCP Compliance EU/ROW Seagen International GmBH
Conference Day Two
1:00 PM PANEL DISCUSSION: ENSURING INTEGRITY THROUGHOUT THE AUDITING PROCESS
- Explore the moral and ethical standards most commonly missed that can be identified through an effective audit
- How data integrity differs in an internal to external context, and gauge what steps can be taken to ensure vendors deliver at a required standard
- Realise how the validation process is crucial to audits by understanding what processes are under your responsibility, whether these standards match with your chosen vendors, all whilst in-keeping with required regulatory standards.
- Look at processes on sites, documentation is there, information is included, document can be easily located
- What can you do as a person or group to ensure the integrity of data. Learn how to manage these steps with a risk-based approach
Check out the incredible speaker line-up to see who will be joining George.
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