1 Hour and 15 Minute Video | Eugene Reilly, FDA Center for Devices and Radiological Health (CDRH) Office of Compliance & Keisha Thomas, FDA Center for Devices and Radiological Health (CDRH) Office of Compliance
 

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.

Topics Covered

  • 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

Participants that will find this webinar most beneficial will be those involved in medical device and diagnostic companies.  Job titles of attendees that will be most applicable for this session will be:

  • Quality Assurance
  • Regulatory
  • Quality Systems
  • Quality Engineering

 

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

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

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

Eugene Reilly is a program analyst in FDA’s Center for Devices and Radiological Health (CDRH) Office of Compliance and works on the systems that process, display, and analyze compliance and enforcement information. Eugene has been with the FDA’s Center for Devices and Radiological Health in the Office of In Vitro Diagnostic Device Evaluation and Safety as a clinical reviewer and compliance officer and the Office of Surveillance and Biometrics working with adverse event information. Prior to and during his time with FDA, he is a programmer focusing on XML, Python, and Java for databases, web based applications, and computer graphics.

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

Keisha R. Thomas is the Deputy Director for the Division of Enforcement A, in the Center for Devices and Radiological Health’s (CDRH), Office of Compliance. She has been at the FDA, CDRH for ten years.  During that time, Ms. Thomas has been a Quality System Specialist, primarily responsible for the evaluation of QS/GMP reviews within CDRH for legal actions and regulatory reviews to ensure proper evidence development and provided QS/GMP guidance to FDA field investigators and the medical device industry.

Prior to becoming a dedicated QS specialist, Ms. Thomas was a compliance officer responsible for reviewing inspection reports for foreign and domestic medical device manufacturers, premarket approval applications for new medical devices, as well as classifying recalls and reviewing root cause determinations.

Purchase Video Recording

$395
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