Creating QSR-Compliant CAPA Systems: A Practical Guide for Devicemakers

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Creating QSR-Compliant CAPA Systems
A Practical Guide for Devicemakers

An effective corrective and preventive action (CAPA) program is integral to a successful quality management system.

Ten of the industry’s top experts, who have together managed thousands of root cause investigations and successfully opened and closed more CAPAs than they can remember, share everything from the nuts and bolts of CAPA management to the most innovative best practices.

Creating QSR-Compliant CAPA Systems provides you with a comprehensive knowledge of CAPA management that will help you avoid trouble, including:

  • How to assemble CAPA teams and assign owners to run them using a cross-functional approach, breaking down company silos in the process
  • How to gather, measure, organize, analyze and store data on key quality metrics
  • How to establish SOPs that cover all CAPA activities
  • How to use risk assessment in developing a plan to correct and prevent problems
  • And much more…

 The report also explains the objectives FDA investigators uses to evaluate the way you run your CAPA system:

  • Compliance with the Quality System Regulation
  • Sources used to identify problems
  • Examination of unfavorable trends
  • Quality of the data information system
  • Statistical methods
  • Failure investigations
  • Corrective action
  • Evaluation of corrective action’s effectiveness
  • Verification that corrective and preventive actions were implemented and documented
  • Dissemination and management review of CAPA results

Bonus Checklist: The report includes a comprehensive checklist to make sure you’ve covered all the bases.

Whether your company is small and just beginning to build its CAPA system or medium to large and looking to improve or fine-tune your system, these experts tell you how. They are: Dan O’Leary of Ombu Enterprises LLC, Deborah Lydick of Catalyst Advantage Group; Jim Shore, a board member at the American Society for Quality and former director of quality at Nypro; John Freije of Freije Quality Engineering; Joe Goodman of Sparta Systems; Denise Dion of EduQuest; Nancy Singer of Compliance Alliance; James Eric Miller of Roche Diagnostics; Barbara Immel of Immel Resources; and Ginette Collazo of Ginette M. Collazo Inc. 

Creating QSR-Compliant CAPA Systems walks you through everything you need to know to plan, implement and manage an effective CAPA system.

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Who Will Benefit

  • Quality managers
  • Process owners
  • Investigators assigned to improvement opportunities
  • Quality engineers
  • Manufacturing engineers
  • Supervisors
  • Internal quality auditors
  • Documentation specials

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