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  • Expectations of a Medical OEM during a Design Control Audit

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - Sep 26, 2013 10:00 AM
  • End Time:
  • Thursday - Sep 26, 2013 11:00 AM
  • Location:
  • Online
  • This training on handling a design control audit by the FDA will provide attendees an understanding of what a medical OEM should anticipate during an audit. Learn the best practices to make sure your product design control files are ready for an audit.

    Why Should You Attend:
    The FDA has become more stringent in their examination of medical OEM procedures, process, and data. Many medical device 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.
    Medical device companies also have to ensure compliance with standards such as 21 CFR 820, ISO 13485:2003, ISO 14971:2007 and so on. Design History Files and validations need to be up to date to meet current standards. The FDA expects 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.
    This webinar will explain the process companies should follow for developing a standard procedure to identify what is expected for design control during such an FDA audit. Attendees will learn the practical steps they can follow to ensure product design control files are ready for the FDA’s scrutiny.

    Areas Covered in the Webinar:
    -Multi-functional team approach/responsibility
    -Dealing with the FDA
    -Phase by phase check list – design process
    .Design input/output
    .Design verification/validation
    .Design changes
    .Design review
    -Design History File (DHF)
    -Gap analysis – data gathering for the design history files
    -Risk assessment
    -Design changes
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