Topics
- Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to controlled documents
- Brief introduction to Lean Documents and Lean Configuration
- Lean principles applied to controlled documents
- Typical controlled documents and functions
- Lean principles applied to configuration of electronic QMS software
Who should Attend
Supervisors, Managers, Vice-Presidents and Directors in the areas of: Manufacturing Engineering, R&D, Operations, Quality Assurance and Document Control.
