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.
Demystifying the Quality Management System and Controlled Documents 2018 covers topics such as:
- 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
Demystifying the Quality Management System and Controlled Documents 2018 brings together:
- 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
