Medical Device 2012 - Lean Project Management For U.S. FDA-Regulated Industries

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".

Areas Covered:
- Meet key requirements of the CGMPs/ISO with formal project mgmt.
- "Failing Fast" Formal Lean Project Management
- The Three Most Common Tools - Gantt, CPM, PERT
- Work breakdown Structure, Milestones, Tasks
- Drive Success or Failure Fast
- The Build, Measure, Learn, Re-evaluate Loop
- A Suggested New Product Template
- One Major, But Often Neglected, Use