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.
||Sep 30 - 30 Sep, 2014
Marie Dorat, CQA,CAA is a QA/RA compliance, GxP Training and International product registration Consultant in the Pharmaceutical/Medical Device & IVD Industry She also is the CEO of IPRF, LLC which specializes in helping established and start-up companies process the necessary documents for international product distribution.