🎤  José Mora       |  📅  May 03, 2023   |  🕒  11 AM Eastern Time US


Description:

The Master Validation Plan (MVP) is a critical document that outlines the overall approach and strategies for validating a medical device product or process. The Global Harmonization Task Force (GHTF) published guidance in 2004 to help medical device manufacturers develop a comprehensive MVP that meets international regulatory requirements.

The MVP is a comprehensive and dynamic document that provides an overview of the validation activities required throughout the entire product lifecycle. It covers the product design, development, manufacturing, and post-market surveillance phases. The MVP outlines the validation approach, the roles and responsibilities of the team members involved in the validation process, and the specific validation activities required.

Given the never-ending volume of information, the lean documents and lean configuration approach provides a single source of truth and streamlined data set to help create and manage an MVP.


AREAS COVERED IN THE SESSION:

  • Introduction to principles of lean documents and lean configuration
  • Define the scope of the MVP
  • Discovery and preparation
  • Master Validation Plan (MVP) importance and expectations
  • Development of and typical outline of an MVP
  • Site-specific considerations
  • Summary
  • Conclusion


WHO SHOULD ATTEND:

  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Risk Management Professionals
  • Genesis of chaos: How did we get here?
  • Document problems and document system problems
  • How the traditional approach generates waste
  • Product information vs. Process information
  • Theory of Lean Documents
  • From lean manufacturing to lean documents
  • Key principles of lean documents
  • Lean configuration elements


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