How to Develop a Master Validation Plan

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Description:

Every medical device company (OEM) must meet certain standards for validation of its transfer plans, facilities, clean rooms and processes. These standards apply for OEM’s and suppliers to OEM’s. Many medical companies have never had a Master Validation Plan for their facilities, processes or suppliers. This is an important standard to have when being audited to show on big picture compliance to FDA and foreign standards.

This webinar on “How to Develop a Master Validation Plan” (also known as Validation Master Plan) will provide a step-by-step procedure for all medical device companies and their suppliers that are in need of developing a plan for product/equipment transfer, facilities, processes or to develop a company standard.

Areas to be Covered:

Master Validation Plan content
Revision history
Background
Objective
Purpose
Scope
Project approach
Key activities
Project organization
Communication plan
Quality Assurance
Facility approach
Validation approach
Schedule
Budget …and more

Who will Benefit:

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
Auditors
Suppliers to medical OEM’s
Consultants

Robert Braido

Robert Braido has 40 years of experience in the medical industry. He is president of Visionary Consulting LLC and has been consulting with medical OEM’s and CMOs for over 7 years. Mr. Braido’s has a broad breadth of medical industry experience in prototype/product development, global strategic/tactical planning, technical due-diligence/gap analysis for acquisitions, engineering, operations and business development. He has had great success working at Ethicon Endo-Surgery a J&J Company, Baxter Healthcare, Teleflex Medical, GW Plastics and The Tech Group with increasing responsibilities to the level of VP of Advanced Technologies. He was a member of the Board of Directors for the Society of Plastic Engineers Medical Division for over 10 years and elected Chairman of the Medical Division twice.

Mr. Braido was selected as a member of a Johnson & Johnson Integration Team that took a small fledgling endoscopic medical device company with totally new products, technologies and structure from $75 million to $850 million in 5 years. His career is built on the ability to motivate, lead and coach people in different disciplines throughout the medical industry. The key factor has been driving innovation.

Mr. Braido was elected, as the Consortium Chairman for the Government Reinvestment Program with MIT, the National Science Foundation and seven leading Fortune 200 companies to commercialize 3D Printing and emerging technologies in plastics and metal. He represented J&J as the principal investigator in the development of 3D Printing with the consortium. He has also been an independent reviewer for the National Science Foundation, J&J, MIT, EdgeOne Medical and others.

He has published numerous technical and leadership articles and white papers. In the past he has shared his extensive experiences at seminars, workshops, technical conferences, symposiums and webinars on subjects relating to the medical and plastics industries on due-diligence/gap analysis, product development, plastic and metal manufacturing, plastic product and equipment transfers, compliance, leadership and developing an innovation culture.

This product is currently out of stock and unavailable.

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  • 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