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Ensuring a successful new product introduction in medical product manufacturing 


May 15, 2019 | Webinar

Scaling and de-risking the transition

Webinar | 3PM London/10AM New York


In this webinar, we’ll start from the beginning, which is concept, and continue to full production ramp, regulatory submission support, and conclude with final product release/ramp. We will explore at a high level the systems, techniques, and resources and learn how to weigh, plan and avoid trade-offs that increase transfer risk. You will also see how team skill set selection, defined deliverables, meeting cadence/focus alignment, and clear senior level support and governance are so critical to success.

Key Learning Objectives


  • Analyze customer/product requirements, scale, scoping the launch
  • Understand customer-required effort, data inputs and output requirements
  • Learn importance of and possible ways to de-risk product supply continuity
  • Explore the five basic launch drivers: Documentation, Resources, Facility/Equipment, Materials, Validation/Regulatory
  • Understand importance of dFMEA, pFMEA, Master Validation Plan, Quality Control plans structure
  • Learn how to do a robust validation assessment; challenges and possible solutions
  • Gain insight into supply chain hurdles, considerations
  • Identify startup and ramp considerations, post-launch service needs
  • Understand the regulatory path and global timing requirements

 

 

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