Comprehensive Business Process Assessment for Medical Device Companies – Case Study, Validation Plan and Protocols – 4 Hours Virtual Seminar

In this seminar, we will discuss a comprehensive assessment of a business to establish its assets and liabilities to evaluate commercial potential. We will compare actual performance with potential desired performance in our case study weather to transfer or invest in keeping medical device operations in-house or decide to transfer operation to a contract manufacturer (CMO) from a successful case study. What are the options and next steps to transferring it to the right internal facility or CMO? It will also cover developing a Master Validation Plan, which could be used as a Master Project Plan. It will not only cover the Master Validation Plan, but you will also learn how to develop and write the Protocols (IQ, OQ, PQ) to execute the validations as part of the Validation Plan to meet FDA regulations.

Every medical device company (OEM) and their CMO’s 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 CMO’s. This seminar will instruct the participant on how to develop the Master Validation Plan and Protocols that will show how to meet the FDA and ISO standards for validations. This webinar 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, processes and facilities.


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.

Session 1

Comprehensive Business Process Assessment for Medical Device Companies – Case Study


  • Corporate Management Responsibility
  • Team functions
  • Comprehensive Business Assessment
  • Comparison of Actual Performance with Potential Desired Performance
  • Decision Making
  • Keeping Operations In-side or Transferring
  • Choosing a “World Class” Contract Manufacturer
  • Request for Information (RFI), Request for Proposal (RFP), Request for Quote (RFQ)
  • Supplier Audits
  • Final Selection & Contract Negotiation
  • Project Management
  • Supply Chain/Inventory
  • Introduction to Master Validation Plan
  • Introduction to Protocols/Validations
  • Transfer Process to an in-house facility or Contract Manufacturer
  • Benefits
  • Pitfalls
  • Post Review/Lessons Learned

Session 2

Developing a Master Validation Plan


  • Develop a Master Validation Plan
  • Content
  • Background
  • Objective
  • Purpose
  • In-Scope, Out of Scope
  • Project approach
  • Key activities
  • Project organization
  • Communication plan
  • Quality Assurance
  • Facility approach
  • Protocol and Validation approach
  • Schedule
  • Budget

Session 3

Develop and write IQ, OQ, PQ Protocols to Execute Medical Device Validations


  • Management Responsivities
  • Planning
  • Protocol Writing
  • IQ
  • OQ
  • PQ
  • Validation Plan
  • Validation Approach
  • Objectives
  • Protocol Plan
  • Protocol Approach
  • Establishing Protocol Process
  • Quality Assurance
  • Execution

  • Quality Departments
  • Validation Departments
  • Research and Development Departments
  • Product Development Departments
  • Production Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • OEM and Contract Manufacturing Senior Management
  • Decision Makers in regulated industries
  • Acquisition Executives
  • Private Equity Executives
  • Business Development
  • Pilot Plant Manager
  • Project and Process Engineers
  • Facility Engineers and Managers
  • Supply Chain Managers
  • Global Contract Manufacturing Transfer Teams
  • Global Strategic Managers
  • Quality and Corporate Auditors

Contract Manufacturers:

  • Decision Makers in regulated industries
  • Business Development
  • Contract Manufacturers
  • Plant and Production Managers
  • Operation Managers
  • Engineering and Contract Manufacturing Transfer Teams
  • Project Management Teams
  • Project and Process Engineers
  • Quality and Validation Teams
  • Consultants

Many device manufacturers are rethinking their business models, whether to invest in upgrading equipment, technology, new personnel, transfer it to a lower cost in-house facility or transfer it to a contract manufacturer. In many cases this could save the OEM from investing in costly bricks and mortar, new technology and higher labor cost. This seminar will show you alternatives to freeing up cash flow and floor space for new product initiatives. You will learn how to use skills and techniques to make decisions that could save money, time and people. We will explore the importance of quality, cost, on time delivery and flexibility in making the right decisions.

CMO’s have to also be ready for a seamless transfer of operations by understanding their responsibilities to the OEM and the requirements for a medical device transfer, including the transfer process, validations and the pitfalls that could lead to delays.

  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