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Avoiding Re-Inspection through FDAs 13485 Voluntary Audit Report Submission Pilot Program

Our Price: $395.00

Product Code: WB-7002

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About the Product
Includes 1 hour and 15 minute Windows Media Video File and PowerPoint presentations for immediate download.

In June of 2012 the FDA launched the Voluntary Audit Report Submission Pilot Program, which allows medical device companies to willingly submit various audits in exchange for inspection relief for one year. Through this program, the FDA aims to leverage audits conducted by other accredited regulators to assist in setting risk-based inspectional priorities. The FDA will test the programs viability over the next two years and will not preclude the conduction of PMA preapproval inspections or for-cause inspections. Many industry participants have expressed interest in utilizing this program to avoid bi-annual audits, but have questions surrounding appropriate qualifications, procedures and outcomes.

  • 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

Eugene Reilly
Program Analyst
FDA Center for Devices and Radiological Health (CDRH) Office of Compliance

Keisha Thomas
Operations Analyst
FDA Center for Devices and Radiological Health (CDRH) Office of Compliance

Target Audience

  • Quality Assurance
  • Regulatory
  • Quality Systems
  • Quality Engineering

Target Industry

  • Medical Device
  • Diagnostic

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