How to Develop a Master Validation Plan
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Every medical device company (OEM) must meet certain standards for validation of its transfer plans, facilities, clean rooms and processes. These standards apply for OEM’s and suppliers to OEM’s. Many medical companies have never had a Master Validation Plan for their facilities, processes or suppliers. This is an important standard to have when being audited to show on big picture compliance to FDA and foreign standards.
This webinar on “How to Develop a Master Validation Plan” (also known as Validation Master Plan) will provide a step-by-step procedure for all medical device companies and their suppliers that are in need of developing a plan for product/equipment transfer, facilities, processes or to develop a company standard.
Areas Covered in the Session :
- Master Validation Plan content
- Revision history
- Background
- Objective
- Purpose
- Scope
- Project approach
- Key activities
- Project organization
- Communication plan
- Quality Assurance
- Facility approach
- Validation approach
- Schedule
- Budget …and more
Who Should Attend:
- OEM Senior management
- Supplier Senior management
- Managers and directors
- Managers setting up new facilities and product lines
- Plant and facility managers
- End-users responsible for design control and product development
- R&D and product development
- Project managers
- Facility and clean room designers
- Process engineers and managers
- Validation engineers
- Quality management and engineers
- Auditors
- Suppliers to medical OEM’s
- Consultants
Course Director: ROBERT BRAIDO
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