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. It 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, processes or to develop a company standard.
Why You Should Attend:
The Validation Master Plan webinar describes the way an organization may approach validation; help identify who 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.
- Overview of Validation Master Plan
- What is a VMP?
- Which regulations apply?
- What topics are covered in the VMP?
- Master Validation Plan content
- Project approach
- Key activities
- Project organization
- Communication plan
- Quality assurance
- Who are the VMP Key contributors? Defining their roles
- Quality Assurance
- Regulatory Affairs
- Implementation of the VMP
- Training requirements
- Controlling and updating the VMP
- 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 Should Attend:
- Medical device/IVD companies & Manufacturers
- Quality Assurance Departments
- Quality Engineers
- Validation Departments
- Documentation Departments
- Production Departments
- Manufacturing Departments
- Regulatory Affairs Departments
- Operations Departments