Validation Master Plan – A Complete Package

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.

Areas Covered in the Session :

  • Overview of Validation Master Plan
    • What is a VMP?
    • Which regulations apply?
  • What topics are covered in the VMP?
  • Master Validation Plan content
    • Purpose
    • Scope
    • Project approach
    • Key activities
    • Project organization
    • Communication plan
    • Quality assurance
  • Who are the VMP Key contributors? Defining their roles
    • Quality Assurance
    • Regulatory Affairs
    • Operations
    • Engineering
  • Implementation of the VMP
    • Training requirements
  • Controlling and updating the VMP
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?

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

MD2418

Marie Dorat

Marie Dorat, CQA,CAA is a QA/RA compliance, and Training Consultant in the Pharmaceutical/Medical Device & IVD Industry. She is the CEO of IPRF, LLC which specializes in helping established and start-up companies develop and/or update their quality management systems. IPRF also assists companies process the necessary documents for international product distribution.

Ms. Dorat has 14 years experience in quality assurance and regulatory affairs in the Pharmaceutical/Medical Device & IVD industry, including GxP Auditing Quality Management System development, Training, validation and Supplier Management Program development in the US and internationally. She has held a number of senior QA/RA. She has worked for several companies. She has lectured at conferences and on training courses on QA and GXP topics.

She has also worked directly with various companies in the Pharmaceutical & Medical Device industry, assisting with international new product registrations as well as rebranding products after an acquisition or merger. She has developed a process to reduce time to market for most companies by several months.

She conducts training courses for both public groups and in-house on topics including: International Product Registration project management, Auditing 101, Writing and managing Quality Systems, GCP , Regulatory requirements for Clinical Trials, FDA audit and EU inspections.

membership
  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT


  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance