Quality Management Essentials: Expert Advice on Building a Compliant System

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Quality Management Essentials
Expert Advice on Building a Compliant System

A strong quality management system is the foundation of a drug or devicemakers success.  A shaky quality system is sure to lead to a company’s downfall.

In this new report from FDAnews, top authorities in quality management give insight and advice on the features that make a system strong and effective. This collection of essays from five of the drug and device industry’s most knowledgeable practitioners illustrates exactly how to create or update a quality management system that hits all the right notes.

In Quality Management Essentials you will learn:

  • The role senior management should play in the quality system
  • Methodologies for identifying, analyzing and addressing risk
  • How to conduct root cause analysis
  • How to evaluate the effectiveness of your training program
  • The types of internal audits companies should conduct and when
  • How to manage and monitor contractors

Step into the classroom. These five experts average more than three decades of experience in developing effective quality systems:

  • David Chesney, Principal and General Manager, DL Chesney Consulting LLC
  • Susan Schniepp, Fellow, Regulatory Compliance Associates, Inc.
  • Steven Sharf, President, GMP Concepts 
  • James Vesper, Director, Learning Solutions
  • Lori Richter, Senior Consultant, ValSource

Order your copy of Quality Management Essentials: Expert Advice on Building a Compliant System for advice from top experts on how to strengthen your quality system.

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PDF Edition


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PDF Edition — $397

Who Will Benefit

  • Director of Quality Control/Assurance
  • Regulatory Affairs/Compliance Officer
  • Senior management
  • Training director
  • Auditor

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