Norbert Dank, Clinical Risk Management Lead  at UCB
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Norbert Dank

Clinical Risk Management Lead 

Check out the incredible speaker line-up to see who will be joining Norbert.

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GCP and Inspection Readiness 2019 Agenda

GCP and Inspection Readiness 2019 Agenda

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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