EU MDD Requirements
This 90-minute webinar on Lean Project Management for U.S. FDA Regulated companies will show how you can incorporate basic lean principles for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale, while addressing FDA / CGMP requirements.
Both the FDA and the EU MDD expect companies to manage projects formally -- to include regulatory requirements, design and/or change control, with consideration of all applicable standards, and to demonstrate "progress against plan".
This webinar will provide valuable guidance to regulated companies in development and implementation of new Lean Project Management Planning concepts 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 common tools will be discussed. "Hit the ground running" with one very simple approach using common Excel- or Word-type PC applications programs. The speaker will discuss a few simple but powerful tools, the regular use of which will virtually eliminate "fire fighting" in a new project. You will learn how to incorporate lean principles into project management and reduce scheduling uncertainty, aid project team communication, prevent incomplete projects when time is running out, decrease product liability, assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.