The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: September 23, 2015 from 1pm to 2pm
Location: Online
Street: 5939 Candlebrook Ct
City/Town: Mississauga
Website or Map: https://compliancetrainings.c…
Phone: 4169154458
Event Type: webinar
Organized By: Compliance Trainings
Latest Activity: Aug 7, 2015
Description :
Do you find yourself constantly struggling to create, manage, and maintain all of the information found in DHFs, DMRs, and DHRs - which is often redundant, repetitive, and chained together in a cumbersome way?
Do you find that your design and manufacturing resources are spending way too much time on documentation and not enough on engineering and design?
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
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