Product Details
How should you respond to citations of nonconformities from a notified body?
Preparing your response can be daunting. There’s only 15 days to craft a response to the auditing body so you’ll need to hit the ground running.
Planning an Audit Response: How to Handle MDSAP Findings will show you how to develop a standard operating procedure (SOP) that tells everyone involved what needs to be done and when to do it. Using real-life examples that show appropriate versus inappropriate responses, this management report provides instructions for an audit response, including:
- 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 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 — Planning an Audit Response is a must.
About the Contributor
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.
Who Will Benefit
- Senior management
- Quality management
- Regulatory management
- Quality engineers
- MDSAP auditors
Add to Cart
Contributor:
Connie Hoy
ISBN-13:
978-1-60430-124-3
Publication date:
April 2020
Page count:
165
Multi-user Access
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Books Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Our Guarantee
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.