Developing IQ, OQ, PQ Protocols as Part of a Validation Plan

  • Product Id : MD2097
  • Category : ,
  • Presenter :
  • Scheduled On : December 12 2018 1:00 pm
  • Duration : 60 Minutes

Every medical device company (OEM) and their CMO’s (suppliers) must meet certain standards for validation of all its processes, manufacturing operations, infrastructure, transfer plans, facilities, and clean rooms. These standards apply for OEM’s and suppliers to OEM’s.

This webinar will instruct the participants on how to develop the validation protocols that will show how to meet the FDA and ISO standards for validations. The planning and execution for your facilities, processes or suppliers will be addressed. This is an important process to establish before being audited to show compliance to the FDA and foreign standards.

This webinar defines the step-by-step procedure for all medical device companies and their suppliers that are in need to plan and execute validation protocols. This webinar can also prepare you for product or equipment transfer; facility or processes upgrade.

Areas Covered in the Session :

  • Management Responsivities
  • Effective Planning
  • Effective Execution
  • Validation Plan
  • Validation Approach
  • Objectives
  • Protocol Plan
  • Protocol Approach
  • Establishing Protocol Process
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Quality Assurance ….and more
Who Will Benefit:

  • OEM Senior Management Teams
  • CMO Senior Management Teams
  • Managers and Directors
  • Managers setting up new facilities and product lines
  • Supply Chain Managers
  • Plant and Facility Managers
  • Plant and Facility Engineers
  • Facility Designers
  • Clean Room Designers
  • End-users responsible for Design Control and Product Development
  • R&D and Product Development Teams
  • Project/Program Managers
  • Process Engineers and Managers
  • Manufacturing Departments
  • Validation Departments
  • Project Managers
  • Quality Management Departments
  • Auditors
  • Suppliers to Medical OEM’s
  • Consultants

MD2097

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.

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