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Updates on Avoiding Re-Inspection through the FDA’s 13485 Voluntary Audit Submission Pilot Program
Updates on Avoiding Re-Inspection through the FDA’s 13485 Voluntary Audit Submission Pilot Program


 
Our Price: $395.00

Product Code: WB-7047
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About the Product
Includes 1 hour Windows Media Video File and PowerPoint presentations for immediate download.

This timely session will provide an updated overview of the FDA’s pilot program, primarily focusing on the progress made over the past 6 months and will specifically include and address updated information on related FDA work plans, redact information, and issues relating to e-submitter/gateway.

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

Speakers:

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

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


Target Audience

  • Quality Assurance
  • Regulatory Affairs
  • Quality Systems

Target Industry

  • Medical Devices
  • Diagnostics

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