Effective Internal Audits and Quality Control Units for Devicemakers

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It's estimated that 75 percent of devicemakers conduct internal audits “only because we have to — to comply with FDA and ISO regulations.”

Some take unfortunate short cuts, using part-time auditors or letting their own management do the audits and write the reports.

No wonder so many inspections end with FDA 483s and warning letters.

You can do better — much better.

The new management report from FDAnews, Effective Internal Audits and Quality Control Units for Devicemakers, will show you how a strong internal audit program and quality control unit (QCU) can ensure your compliance with FDA requirements … plus reduce waste and redundancy … and even improve your business operations.

Establish a Successful Internal Audit Program and
QCU That Will Satisfy the FDA — And More

You'll start by learning step-by-step what it takes to create and implement an effective, independent internal audit program and quality control unit (QCU).

Quickly, you'll begin to see how important internal audits can be for your organization as a proactive tool and not just a "reaction" to a requirement.

And, you'll come to understand the FDA's expectations of your QCU, how to set up your unit properly and in compliance, and how to fix any problems with an existing QCU.

Specifically, you'll learn:

  • Why audits are needed and how companies can better use audits;
  • How the “we do audits simply because we have to” mentality leads to QSR violations, recalls and poor company performance;
  • How to structure an audit program and score it to assure that it’s effective;
  • Who should be your auditor;
  • Proven methods to create a risk-based audit schedule and determine audit frequency;
  • How to sell effective quality audits to management;
  • How to document and report nonconformances;
  • The 4 common mistakes that show up on 483s and warning letters — and how to eliminate them with effective internal auditing;
  • Critical expectations of the QCU — what the FDA is looking for during an inspection;
  • Best practices for ensuring you’re managing an effective QCU;
  • And more

Gain Understanding of Why Failures Occur —
And Use Tested 'Working Tools' to Move Forward

Effective Internal Audits and Quality Control Units for Devicemakers also dissects areas of possible failure and provides practical insights into why an organization like yours may continue to have issues and receive citations.

That's why we've also included a thorough analysis of recent device industry survey data that will help you better understand weaknesses in your operation, diagnose your problems and prevent 483 observations.

You'll also get tried-and-tested 'working tools' that will help you take your internal audit capability to the highest level, including …

Best practices for writing good audit reports and communicating them to your team and management …

Sample audit report in a format that has been successfully used by numerous companies …

An invaluable, comprehensive audit frequency criteria template, and …

Actual warning letter citations from companies like yours, so you can learn from their audit mistakes.

There's no time like the present to address shortcomings you may have with your internal audit program or QCU.

Order Effective Internal Audits and Quality Control Units for Devicemakers TODAY.

Make your internal audit program and QCU a top priority — with a report that will ensure your success.

Order Your Copy Today!

PDF Edition

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Table of Contents

  • Introduction
  • How to Build a Better Internal Audit
  • Understanding the Critical Role of the QCU
  • And More …

View the entire TOC

Who Will Benefit

  • Device manufacturing executives
  • Auditing and compliance officers
  • QA/QC managers and directors
  • Production managers
  • Process development staff
  • Training managers
  • Regulatory affairs professionals
  • General/corporate counsel
  • Personnel new to the industry

Meet the Authors

This report is largely drawn from comments made at FDAnews webinars by Susan Reilly, owner of the consultancy Reilly & Associates, and Crystal Mersh, executive partner with quality control unit consultancy QxP Inc.

Reilly has more than 25 years of quality system and regulatory compliance experience in the medical device arena. Before becoming an independent consultant in 1999, she was director of quality systems at Medical Device Consultants and manager of quality assurance at the Deknatel Division of the Pfizer Hospital Products Group.

Mersh, in her position with QxP, provides quality and compliance consulting and strategic planning services for medical device and pharmaceutical companies. Prior to joining QxP, she was vice president of quality management at Novartis for more than eight years.

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