Avoiding Data Integrity Breaches: A Guide for Drugmakers

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Over the last few years, U.S. and U.K regulators have increased their focus on data integrity with drugmakers.

The result? An uptick in enforcement actions.

With this report, you'll get concrete, proven tools and techniques to help you identify existing — and potential — data integrity problems before they snowball out of control.

And, it will show you how to design and deploy your own remediation strategy, using a risk-based approach to help you prioritize your efforts.

Step by step, you'll see how to create a corporate culture that's conducive to data integrity protection, develop a risk-based oversight and prevention system, and recruit, train and retain employees who will responsibly work to ensure the integrity of your company's data.

Specific knowledge the book will give you includes:

  • Recent case histories highlighting data integrity lapses: You'll learn from other companies' mistakes

  • Tested "working tools" and techniques to help you uncover data integrity issues in your facility

  • Ways to characterize the scale and scope of your issues using methodologies like the compliance maturity curve

  • How to design and deploy a remediation strategy that will address your company's issues

  • How to implement the 5 leading solutions for data integrity issues:

    1. Creating a corporate quality culture

    2. Developing corporate leadership that’s both engaged in quality — and visible

    3. Investigating and addressing problems under a top-notch CAPA system.

    4. Ensuring that employees responsible for entering, modifying, maintaining, reporting and reviewing critical data have the right skill sets and dedication to high quality and ethical standards

    5. Performance management that’s practical, balanced and effective

Take advantage of this opportunity to learn from the successes — and mistakes — of other drug companies similar to yours.

Let Avoiding Data Integrity Breaches: A Guide for Drugmakers show you how to find and fix data integrity problems with a tried-and-tested, proven approach.

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Table of Contents

  • Introduction
  • The Importance of the Corporate Quality Culture
  • How to Identify Data Integrity Issues
  • How to Remediate Data Integrity Issues
  • And More …

View the entire TOC

Who Will Benefit

  • Drug companies
  • Biologic companies
  • Contract manufacturers
  • Contract laboratories
  • Suppliers
  • Law firms

Meet the Authors

This report is largely drawn from comments made at an FDAnews webinar by Marie McDonald, vice president at Quintiles Consulting, and Glen Potvin, senior director at Quintiles Consulting.

McDonald has worked on consulting engagements that span strategy development, program and project planning, process design, quality systems improvement, training and change management.

Potvin has more than 20 years of experience in delivering results through structured analysis, creative problem solving, strategy development and focused project management.

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