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FDAnews Announces — Planning an Audit Response: How to Handle MDSAP Findings Management Report

Planning an Audit Response:
How to Handle MDSAP Findings
An FDAnews Management Report

Despite best efforts to the contrary, having nonconformities spotted by a notified body during an audit does happen. What is the best way to respond?

Companies will be under a strict deadline and under pressure with only 15 days to craft a response to the auditing body.

Planning an Audit Response: How to Handle MDSAP Findings will show readers how to develop a standard operating procedure (SOP) that tells everyone involved what needs to be done and when to do it. This management report provides step-by-step instructions for an audit response:

  • Evaluate the severity of the findings
  • Investigate the root cause
  • Identify corrections and corrective actions
  • Draft a written response to the auditing body
  • Prepare for follow-up audits
  • Establish a timeline that gets it all done by the auditor’s deadline

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

Management Report Details:
Planning an Audit Response:
How to Handle MDSAP Findings
An FDAnews Management Report

Management Report PDF:

Easy Ways to Order:
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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