Design History Files, Device Master Records and Quality Management System for Medical Device Company - Principles of Lean Documents and Lean Configuration 2017

Design History Files, Device Master Records and Quality Management System for Medical Device Company - Principles of Lean Documents and Lean Configuration 2017 is a seminar that provides knowledge on how to apply the principles of lean documents and lean configuration to construct Design History Files (DHFs).

Topics

• How to construct Design History Files (DHFs), Device Master Records (DMRs), and Design History Files (DHFs) using lean document and lean configuration methods
• The fundamental Principles of Lean Documents and Lean Configuration
• A Quality Management System (QMS) for a medical device company using lean documents and lean configuration methods
• How to construct a Design Input Design Output traceability matrix using lean documents and lean configuration methodologies
• Preparing and managing a CAPA system using lean documents and lean configuration methods

Who should Attend

• Quality professionals
• Senior quality managers
• Compliance professionals
• Regulatory professionals
• Manufacturing engineers
• Production supervisors
• Design engineers
• Production engineers
• Quality engineers
• Process owners
• Document control specialists
• Quality auditors
• Medical affairs
• Record retention specialists
• Legal Professionals