Project Management for FDA-Regulated Companies

Topics

• "Failing Fast" Formal Lean Project Management
• Meet key requirements of the CGMPs/ISO; Quality Plans
• Work breakdown Structure, Milestones, Tasks
• The Three Most Common Tools - Gantt, CPM, PERT
• The Build, Measure, Learn, Re-evaluate Loop
• Drive Success or Failure Fast; Fast Cycle / Agile Principles
• One Major, But Often Neglected, Use
• Example: A Suggested New Product Template

Who should Attend

• Senior management
• Project Managers
• Quality Assurance / QAE
• Regulatory affairs
• R&D and Engineering
• Production