Demystifying the Quality Management System and Controlled Documents

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

Demystifying the Quality Management System and Controlled Documents 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 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

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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