Internal Auditing Basics: A Guide for Drug and Device Manufacturers

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Internal Auditing Basics
A Guide for Drug and Device Manufacturers

Internal audits are a critical element of your quality management system. Your approach must be both systematic and documented to remain compliant.

Information from an internal audit provides management with the knowledge they need to show how effectively the company maintains the quality of the product and their processes.

This FDAnews Brief is an introduction for quality management newcomers — a refresher course for more experienced staff — and a training tool for those taking on responsibility for audits.  Readers will learn about:

  • Regulators’ requirements for management review
  • Comparison of FDA regulations to ISO 9001, ASQ Quality System and ICH E10
  • Characteristics of an effective audit team
  • Scheduling and tracking audits
  • Reporting and responding to an audit

The value of an internal audit goes beyond simply regulatory compliance. It can be used to:

  • Identify problems and fix them before a regulatory inspection
  • Improve your processes
  • Train your employees
  • Identify gaps in your processes
  • Keep executive management informed

Internal Auditing Basics: A Guide for Drug and Device Manufacturers demonstrates how to build an auditing operation, including scheduling and reporting, explains regulatory requirements and discusses how to turn audit results into positive improvements.

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Who Will Benefit

  • People new or with little experience in quality management
  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Auditing and compliance officers
  • Production managers
  • Training managers

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