Norbert Dank
Clinical Risk Management Lead
UCB
Check out the incredible speaker line-up to see who will be joining Norbert.
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GCP and Inspection Readiness 2019 Agenda
Main Conference Day 1
Tuesday, September 17th, 2019
3:00 PM Quality Tolerance Limits – Setting Smart Parameters to Ensure Inspection Readiness
- Understand how Quality Tolerance Limits stipulated by the updated GCP guidance should be interpreted, and what it means to be compliant
- Analyze the benefits of Quality Tolerance Limits and what parameters should be considered for implementation
- Deep dive into how Quality Tolerance Limits can be implemented successfully with a case study from UCB and reflect on lessons learned
- Understand the potential impact of Quality Tolerance Limits on future regulatory submissions