Since the first publication of GCP guidelines in 1996, many things have changed. That’s why ICH E6(R2) has been modernised with additional recommendations, focusing on computerized systems and their validation in clinical trials. Do you wonder what has changed – and what this means for your company? Then register now for the QbD Webinar on 6 June, which will focus on GCP Computer System Validation.
This webinar is of interest to sponsors of clinical studies and processes, researchers and/or auditors. It will focus on crucial topics in the field of GCP Computer System Validation: differences between GCP and GMP systems, the way various guidelines and auditors handle GCP, as well as some best practices and hands-on examples.
After a short introduction (10 min), our QbD specialists will give you more insight into the evolution of Good Clinical Practices:
- GCP in theory (30 min): legal aspects, new guidelines and status quo. Focus on Computer System Validation (CSV).
- GCP in practice (30 min): “Clinical Computer Systems inspected – findings and how to anticipate or remediate them.”
- During the Q&A session at the end, you’ll be able to get answers to your questions on the topic.
Interested? Register for the Webinar now!
Unique insights / Duration 70 min / English