Developing a Validation Master Plan

Instructor: Marie Dorat

Description:

This course will provide a step-by-step guidance for medical device companies that need to develop a Validation Master Plan (VMP) for product/equipment transfer, facilities, and processes or to develop a company standard.
The Validation Master Plan describes the way an organization approaches validation; that controls the various aspects of the validation activities; and how production, quality, and management will be involved. The VMP also details the validation requirements for each test/ system/ equipment and will guide the organization in achieving its objectives. 

Why Should you Attend:
This course will provide guidance on best practices for developing and implementing a good plan detailing responsibilities, and deliverables to make validation efficient, and consistent. 

Objectives of the Presentation:
To give a better understanding on

• What is a VMP and how is it valuable to my company?
• What topics are covered in the VMP and to what extent?
• How is the VMP controlled and updated?
• How is the VMP implemented?
• Who contributes to the VMP?

Who can Benefit:

• Quality Assurance
• Regulatory affairs
• Operations Engineers
• Quality Engineers