A Guide for Drug and Device Manufacturers

FDAnews

Internal Auditing Basics:

A Guide for Drug and Device Manufacturers

**An FDAnews Brief**

http://www.fdanews.com/internalauditingbasics    

What are regulators’ requirements for management review?

What are the characteristics of an effective audit team?

These are just a couple of questions manufacturers need to answer before undertaking internal audits. Internal audits are a critical element of a drug or device manufacturers quality management system. 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 processes
  •     Train employees
  •     Identify gaps in 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.

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

FDAnews Book Details:

Internal Auditing Basics:

A Guide for Drug and Device Manufacturers

Price: $177

http://www.fdanews.com/internalauditingbasics    

Easy Ways to Order:

Online: http://www.fdanews.com/internalauditingbasics            

By phone: 888-838-5578 or 703-538-7600

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