Medical Device Nonconforming Audit Findings – Webinar Recording/Transcript

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Medical Device Nonconforming Audit Findings: Corrective Action That’s Right for Your Company

How should you respond to nonconformities from a notified body? Preparing your response can be daunting and can result in additional unnecessary efforts to your organization.

You’ll be under a strict deadline… under pressure … then you find out your corrective plan isn’t right.

Connie Hoy — founder of Hoy & Associates Regulatory Consulting — will provide detailed instructions on how to formulate a plan, how to write the internal corrective actions and how to craft a response to the auditing agency… in ways that work for your company. In addition, she will share real-life examples that show appropriate versus inappropriate responses.

Presentation Takeaways:

  • How to analyze the criticality of the audit findings
  • How to avoid complicating your corrective actions and inadvertently overburdening your organization
  • How to prioritize your plan by identifying corrections and corrective actions
  • How to write a sufficient corrective action and preventive action (CAPA) procedure
  • How to draft an appropriate response to the auditing agency

If you might be tasked with responding to a regulatory audit — or signing your name to one — this presentation is a must.

  • Senior Management
  • Management Representatives
  • Quality Management
  • Regulatory Management
  • Quality Engineers

Meet Your Presenter

Connie Hoy, founder of Hoy & Associates Regulatory Consulting, has over three decades’ experience in the medical device industry. Time and again she and Hoy & Associates have helped companies obtain important global regulatory approvals and pass foreign and domestic audits. She and the firm are well-versed in the workings of the FDA, helping companies of all sizes with presubmission meetings and submission preparation. The firm offers internal auditing and gap analysis for quality management systems and provides full-scope audits including FDA 21 CFR, ISO 13485:2016, Medical Device Single Audit Program (MDSAP) and Electronic Product Reporting, providing audit reports for regulatory agencies that will withstand the most rigorous scrutiny. Ms. Hoy is intimately familiar with the day-to-day challenges of developing strategies and obtaining approvals, developing and maintaining quality management systems and encouraging a culture of compliance. Before forming Hoy & Associates, Ms. Hoy was Executive Vice President of Regulatory, Quality and Clinical Development at Cynosure, a division of Hologic. Prior to that, she served as Senior Vice President of Global Regulatory Affairs and Quality Assurance at Cynosure, Inc. and Vice President, Regulatory Affairs and Quality Assurance, Cutera, Inc.