Duration: 60 Minutes


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This 60 minute webinar on a Design Control Audit by the FDA and other bodies will provide an understanding of what a medical OEM should anticipate during an audit during a design control audit. All medical device companies that are in need of examining their design control process should be aware of what to expect.

The FDA and other authorizing bodies have become more stringent in their examination of medical OEM procedures, process, and data. Many medical industry companies have not completed all their testing and design reviews before commercializing products properly or brought their mature product lines up to current FDA standards and are not in total compliance. This webinar shows the process to be followed for developing a standard procedure to identify what is expected for design control.

For example, companies should be compliant to 21 CFR 820, ISO 13485:2003, ISO 14971:2007, etc. Design History Files and validations need to be up to date to meet current standards. The FDA and other authorizing bodies expect continuous improvement and risk management to be integrated into the company quality system. Old medical devices need to have a risk assessment for each product and updated validations for product and processes. It should describe the risk acceptance criteria as well as roles and responsibilities of each member on the team.

In this webinar, we will discuss practical steps you can follow to make sure your product design control and quality files are ready for an audit. It will also give the attendee guidelines on how to deal with the authorizing bodies.

Areas Covered in the Session :

  • Champion/Multi-functional team approach/responsibility
  • Dealing with the FDA and other authorizing bodies
  • Phase by phase design process check list
    • Design input/output
    • Design verification/validation
    • Design changes
    • Design review
  • Design History File (DHF)
  • Due-diligence
  • Gap analysis – data gathering for the design history files
  • Risk assessment
  • Design changes
  • 483 warning letters
  • Planning to be prepared

Who Should Attend:

This webinar will provide valuable assistance and give a process to all medical device and regulated companies that need to prepare for an FDA or authorizing bodies audit in the future. The employees who will benefit include:

  • OEM and CMO Quality Managers
  • OEM and CMO Quality Engineers
  • End-users responsible for design control and technical files
  • R&D and product development
  • Process engineers and managers
  • Operations and plant management
  • Validation engineers
  • Remediation teams
  • QA, Regulatory Affairs
  • QC and Corporate Auditors
  • All team members who contribute to design history files, clinical, verifications/validations, risk management or technical files
  • Consultants
  • Project managers
  • Supplier management
  • Product transfer engineers
  • All Contract Manufacturers working in the medical industry

Course Director: 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.