29 - 31 October, 2018 | Mercure Hotel Amsterdam City, Amsterdam , Netherlands

Bente Post-Pedersen


Program Lead
Biogen


2:20 PM Risk Assessment and Risk Management for Combination Products

  • Systematic approaches to working with risk management: Establishing full traceability of critical parameters, from the early development phases to the end product being packed and shipped to the end customer
  • Using risk management to develop the control strategy and well documented design transfer of medical devices and combination products
  • Using a quality risk management system as a basis to ensure, monitor and maintain quality throughout the entire product lifecycle
  • Risk-based approaches to design and process validation 
  • Ensuring documentation is clear, transparent and audit-ready


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

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