The U.S. FDA expects companies to manage CGMP projects formally -- to include regulatory requirements, design and/or change control, with consideration of all applicable standards. The EU MDD/MDR and their notified bodies are no different. How can this be done from a project's inception? How can a Project Leader or Project Manager ensure critical elements are not ommitted until late in the project when disaster looms? How to minimize scope creep? This webinar is not a project management certification course. But it does cover basic project management tools and techniques. It addresses the three most common project management tools: 1) Gantt Chart, 2) CPM Network, and 3) PERT Network. It provides valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques 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.
Areas Covered in the Session:
Formal Project Management to Fulfill Common cGMP Requirements
"Failing Fast" Lean Project Management
The Three Most Common PM Tools -- Gantt, CPM, PERT + others
Work breakdown Structure, Milestones, Tasks; Reverse Engineering