FDA-Regulated Companies 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.
The FDA expects companies to manage projects formally, with a written plan -- to include regulatory requirements, design and/or change control, with consideration of all applicable standards, and to demonstrate "progress against plan". The EU MDD and their notified bodies are no different.
Meet key requirements of the CGMPs/ISO; Quality Plans
"Failing Fast" Formal Lean Project Management
The Three Most Common Tools - Gantt, CPM, PERT
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, which have subsequently passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.