! function(o, t, e, a) { o._aoForms = o._aoForms || [], o._aoForms.push(a); var n = function() { var o = t.createElement(e); o.src = ("https:" == t.location.protocol ? "https://" : "http://") + "support.flex.com/acton/content/form_embed.js", o.async = !0; for (var a = t.getElementsByTagName(e)[0], n = a.parentNode, c = document.getElementsByTagName("script"), r = !1, s = 0; s < c.length; s++) { if (c[s].getAttribute("src") == o.getAttribute("src")) r = !0; } r ? typeof(_aoFormLoader) != "undefined" ? _aoFormLoader.load({ id: "482592df-d182-4ff0-be56-eebb313261fa:d-0001", accountId: "39314", domain: "support.flex.com", isTemp: false, noStyle: false, prefill: false }) : "" : n.insertBefore(o, a) }; window.attachEvent ? window.attachEvent("onload", n) : window.addEventListener("load", n, !1), n() }(window, document, "script", { id: "482592df-d182-4ff0-be56-eebb313261fa", accountId: "39314", domain: "support.flex.com", isTemp: false, noStyle: false, prefill: false });

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



You can learn more about our use of cookies and your choices here. By clicking on any link on this page or clicking "OK, I agree", you are giving your consent for us to set cookies.