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.
Order Your Copy Today
PDF Edition — $397
Who Will Benefit
Director of Quality Control/Assurance
Regulatory Affairs/Compliance Officer
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