Demystifying the Quality Management System and Controlled Documents 2018

Demystifying the Quality Management System and Controlled Documents 2018 is a workshop dedicated to maintaining and improving 21 CFR 820 Quality Systems for medical device.

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
• 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
• Risk management process as per ISO 14971, plan and file using LDLC
• CAPA system using lean documents and lean configuration methods
• Highly Interactive Practical Sessions that will be conducted on each day

Who should Attend

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