2013 - 21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820, yet is based on solid principles and proven practices.

Areas Covered in this Session:

• Brief introduction to Lean Documents and Lean Configuration
• Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documents
• Basic functions found in a life sciences manufacturing plant
• Key types of controlled documents and records for manufacturing
• Quality Management System (QMS) elements controlled via documentation
• Bringing it all together