Demystifying the Quality Management System and Controlled Documents

Date	Oct 11, 2018
Time	10:30 AM EDT
Cost	$73804.50
Online

This highly interactive two day course on principles of lean documents and lean configuration will present a new approach that is based upon solid principles and proven practices. During this seminar, the theory of lean documents and its corollary applied to lean configuration will be used in order to construct, write, and configure the types of documents and records necessary for medical device design and manufacturing.

Learning Objectives:

• Understand the fundamental principles of lean documents and lean configuration
• Understand how to construct Design History Files (DHFs), Device Master Records (DMRs), and Design History Files (DHFs) using lean document and lean configuration methods
• Understand how to construct a design input, design output, traceability matrix using lean documents and lean configuration methodologies
• Be able to prepare a Quality Management System (QMS) for a medical device company using lean documents and lean configuration methods
• Be able to prepare and manage a CAPA system using lean documents and lean configuration methods
• Understand Risk management process as per ISO 14971, plan and file using LDLC
• Utilize Highly Interactive Practical Sessions that will be conducted on each day

Who Should Attend :

• Quality Departments
• Regulatory Departments
• Compliance Departments
• Production Departments
• Manufacturing Departments
• Engineering Departments
• Research and Development Departments
• Production Departments
• Process Owners
• Quality Auditors
• Document Control Specialists
• Record Retention Specialists