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Part 2 Avoiding Re Inspection through FDA’s 13485 Voluntary Audit Submission Pilot Program

TOPICS COVERED IN THIS WEBINAR

  • Defining program qualifications for:
    • Manufacturers
    • Audit data/ requirements
    • Accredited third parties
  • Program benefits and risks for industry manufacturers and regulators
  • Step by step guidance for audit submission
    • Overcoming E-Submitter/ Electronic Submissions Gateway (ESG) issues
    • Outlining resources for manufacturers

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