2015 - Webinar On Key Regulatory Documents: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) and Design Dossier

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 Configuration
Quality System Regulation, 21 CFR Part 820, and ISO 13485 as it applies to DHF, DMR, and DHR
Design History Files (DHF) content, development, and management
Device Master Records (DMR) content, development, and management
Device History Record (DHR) content, development, and management
Applying lean principles to creating, developing, and managing a DHF
Applying lean principles to creating, developing, and managing a DMR
Applying lean principles to creating, developing, and managing DHRs
Who Will Benefit:
A must for all Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
R&D
Manufacturing Engineering
Design Assurance
Quality Assurance
Operations
Document Control
Lean Program Leaders