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FDA Quality System Regulation for Medical Devices (21 CFR Part 820): A Practitioner's Guide to Management Controls (sections 820.20 Management ... 820.22 Quality Audit, and 820.25 Personnel)
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About the Author
Donald G. Daugherty is an accomplished medical device quality assurance professional with over 25 years of experience in quality engineering, management, and compliance with some of the world’s largest medical device manufacturing companies. He is highly knowledgeable in requirements of FDA QSR 820, ISO 13485, and ISO 14971, manufacturing process validation (IQ, OQ, PQ), quality system development, Corrective and Preventive Action (CAPA), and quality performance metrics and analytics. He is exceptionally skilled in statistical techniques, process improvement, problem solving, and root cause analysis. Donald G. Daugherty is also a senior member of the American Society for Quality (ASQ) and maintains professional certifications through ASQ as a Certified Six Sigma Black Belt, Quality Engineer, and Quality Auditor.
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Product details
Paperback: 58 pages
Publisher: CreateSpace Independent Publishing Platform (December 19, 2015)
Language: English
ISBN-10: 1522840249
ISBN-13: 978-1522840244
Product Dimensions:
6 x 0.1 x 9 inches
Shipping Weight: 5 ounces (View shipping rates and policies)
Average Customer Review:
1.0 out of 5 stars
1 customer review
Amazon Best Sellers Rank:
#518,200 in Books (See Top 100 in Books)
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