Simplifying Global Compliance
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
- How often SOPs should be reviewed and revised
- 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 — two of them spent more than 25 years at the FDA — 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
Note: This publication will be available in PDF format by April 19, 2018.
Who Will Benefit
- Director of Quality Control/Assurance
- Regulatory Affairs/Compliance Officer
- Senior management
- Training director
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.
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