“Do you have a procedure?” Yes.
“Is your test equipment calibrated?” Yes.
“Is the inspector trained?” Yes.

Is this any way to conduct an audit?

Most auditors go through a yes/no checklist and what you get is a “check box” mentality.

That’s no way to make sure you’re ready for the FDA. Nor is it the way to uncover new opportunities to innovate, improve, and cut costs.

Quality and Regulatory Assurance Expert Rob Packard and Quality Management System Expert Brigid Glass present “Best Practices in Medical Device Auditing” for a better way to prepare for an FDA inspection.

In this webinar,

• Understand why separate audits of support processes are largely unnecessary
• Learn how to complete turtle diagrams for any process in minutes
• Learn a novel approach to auditor selection based upon the process flow
• Understand which questions to ask when you are planning an audit program
• Learn a novel technique for selecting auditors that are best suited for each audit
• Learn how to plan audits more effectively