Project Management 2020 - Project Management for FDA-Regulated Companies

This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.
How can this be done from a project's inception? How can lean principles be incorporated from project inception? What is "failing fast" in the "build, measure, learn, re-evaluate / decide loop"? Can Agile principles mesh with FDA's documentation requirements?
Meet key requirements of the CGMPs/ISO; Quality Plans
"Failing Fast" Formal Lean Project Management
The Three Most Common Tools - Gantt, CPM, PERT
Work breakdown Structure, Milestones, Tasks
Speaker:
John E. Lincoln, consultant, has successfully designed, written over 50 ISO 14971-compliant Risk Management Files / Reports, including FMECA and FTA analysis, many in response to FDA 483 observation,