Overview: This webinar will offer valuable guidance to regulated companies in development and implementation of Project Management Planning and Strategies for new product development, regulatory compliance audit responses, proof of “progress against plan”, and other activities requiring a planned documented rationale.
Three of the most prevalent tools will be discussed. One extremely simple approach making use of common Excel- or Word-type PC applications programs that can be employed immediately. Normal use of a few basic but potent tools will virtually get rid of “fire fighting” in a new project. Regular use can contribute significantly to reduction of scheduling uncertainty, incomplete projects when time is running out, increased item liability, assist in firm-wide price reduction efforts, with less opportunity of recalls, and an improved bottom line.
Why you need to attend: The FDA expects organizations to manage projects formally – to contain regulatory requirements, design and/or change control, with consideration of all applicable standards. The EU MDD and their notified bodies are no different. How can this be performed from a project’s inception? How can a Project Leader or Project Manager make sure critical elements are not omitted until late in the project when disaster looms? How to minimize scope creep? How to conclude a project “on time” and “within budget”? How to gain management support for the Milestones, Tasks, and Timelines? Use the Plan as a powerful tool with FDA auditors. Use variations on these tools for any project, from the smallest to major company projects. Growing high-profile field troubles indicate that a lot project management is poor or non-existent. Get up-front time for correct project planning. These methods are not rocket-science, but call for the implementation of formal strategies with documented and defensible rationale. Use these tools to bring predictability to your company’s product development process. Use them to defend your remediation efforts with the FDA. Use them to prove “progress against plan”.

July 30th, 2011
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