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

Lori-Ann Woodard

Associate Director Quality Compliance Combination Products
Teva Pharmaceuticals

9:05 AM Effective Post Market Maintenance Strategy for Combination Products

  • Outlining the considerations for monitoring and maintenance of combination products throughout the entire project lifecycle
  • What are the impacts of regulatory changes, marketing needs or production issues? 
  • The importance of developing technical documentation and supporting processes: What are the key things to include, implementation strategy and potential risks to be aware of?
  • Managing change: Precisely monitoring the change control process based on the documentation

9:40 AM PANEL DISCUSSION: Combination Product Design Control and Lifecycle Management

  • What are the biggest challenges you are facing currently with developing and managing combination products? 
  • What are the unique characteristics of combination products and how does it impact the design parameters?
  • What are the critical success factors for combination products? What are key requirements and success factors in selecting device manufacturing and design partners?
  • How can different materials influence the design, development and compliance of combination products? 
  • What advice would you give in terms of testing combination products and the critical requirements for essential performance?

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

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