The Best Way to Develop or Improve a Master Validation Plan
Duration: 90 Minutes
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Validation Master Plans (VMPs) are written to guide and implement an organization with its validation strategy. The Validation Master Plan is different from a validation procedure (SOP), which describes the WHY for performing validation activities. The VMP describes the WHERE and HOW of a process validation program.
09/28/2017 11:30 AM09/28/2017 05:30 PMTraining Topic: The Best Way to Develop or Improve a Master Validation PlanInstructor: Regina Fullin
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
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?
Why Should you Attend
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.
Overview of Validation Master Plan
What is a VMP?
Which regulations apply?
What topics are covered in the VMP?
Master Validation Plan content
Who are the VMP Key contributors? Defining their roles
Implementation of the VMP
Controlling and updating the VMP
Who will Benefit
Medical device/IVD companies & Manufacturers
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