Medical Device Nonconforming Audit Findings – Webinar Recording/Transcript
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.
- 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.