A VMP outlines the activities involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. This is critical objective evidence to have when being audited by FDA or registrar auditors for ISO13485.
This session will provide a step-by-step procedure applicable to most if not all medical device companies and their suppliers that need a MVP for product/equipment transfers, facilities qualifications, or new production processes.
Objectives of the Presentation
Why Should you Attend
- 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?
Lack of evidence supporting appropriate process validation is one of the top 5 causes for 483 findings by FDA. The lack of a comprehensive Validation Master Plan (VMP) and well-documented validation procedures are also among the main reasons that the FDA rejects new product submissions. Planning is a critical part of validation and establishing objective evidence of appropriate validation efforts. Establishing a good plan detailing responsibilities, deliverables, and checkpoints is essential to make validation predictable, efficient, and consistent. A VMP describes the way a company approaches validation; that has control over the various aspects of the validation activities; and how production, quality, and management will be involved. The VMP also establishes the validation requirements for each test/system/equipment and will guide the organization in achieving its objectives. Furthermore, a VMP answers the inspector's question: what is your approach towards validation. This webinar provides the creation, implementation, and maintenance of Validation Master Plans.
Who will Benefit
- 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
- Controlling and updating the VMP
- Medical device/IVD companies & Manufacturers
- Quality Assurance
- Quality Engineers
- QA Managers
- 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
- Suppliers to medical OEM's