Description : This must attend webinar presents a fresh new approach based upon solid principles and proven practices - as well as an alternative, applies the Theory of Lean Documents and also formulates a corresponding Theory of Lean Configuration, that avoids many of the pitfalls of traditional ways of preparing these Key Regulatory Documents.Areas Covered in the Session :Brief introduction to Lean Documents and Lean ConfigurationQuality System Regulation, 21 CFR Part 820, and ISO 13485 as it applies to DHF, DMR, and DHRDesign History Files (DHF) content, development, and managementDevice Master Records (DMR) content, development, and managementDevice History Record (DHR) content, development, and managementApplying lean principles to creating, developing, and managing a DHFApplying lean principles to creating, developing, and managing a DMRApplying lean principles to creating, developing, and managing DHRsWho Will Benefit:A must for all Managers, Supervisors, Directors, and Vice-Presidents in the areas of:R&DManufacturing EngineeringDesign AssuranceQuality AssuranceOperationsDocument ControlLean Program Leaders