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)
| Author | : | |
| Rating | : | 4.53 (808 Votes) |
| Asin | : | 1522840249 |
| Format Type | : | paperback |
| Number of Pages | : | 58 Pages |
| Publish Date | : | 2014-09-20 |
| Language | : | English |
DESCRIPTION:
Management Controls include sections 820.20 Management Responsibility, 820.22 Quality Audit, and 820.25 Personnel of this medical device regulation. The Practitioner’s Guide to Management Controls is written for the practitioner to use as a tool to help develop management controls prospectively for a new quality system or to perform gap assessments between existing management controls in a quality system against the FDA requirements and expectations provided in this book.. The Practitioner’s Guide to Management Contro
Donald G. He is exceptionally skilled in statistical techniques, process improvement, problem solving, and root cause analysis. 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,
About the Author 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. 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 exceptionally skilled in statistical techniques, process improvement, problem solving, and root cause analysis. Donald G. He is highly knowledge
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