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Home » Store » Device Products » Medical Device Nonconforming Audit Findings – Webinar Recording/Transcript

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Medical Device Nonconforming Audit Findings – Webinar Recording/Transcript

$287.00
Device Products

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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.

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