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Item #:
19567369
FDA Quality System Regulation for Medical Devices (21 CFR Part 820): A Practitioner's Guide to Management Controls (sections 820.20 Management ...
Item #:
19567369
ZAR 478
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Donald G. Daugherty is an accomplished medical device quality assurance professional with over 25 years of experience.
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What Stands Out
Comprehensive Guidance
This guide provides exhaustive insights into FDA Quality System Regulations, enabling practitioners to navigate complex management controls effectively, ensuring compliance and minimizing risk in medical device operations.
Practical Application
Designed for real-world use, this book translates regulatory requirements into actionable steps for quality audits and personnel management, streamlining processes for better regulatory adherence and organizational efficiency.
Expert Insights
Authored by industry experts, the guide imparts valuable knowledge and best practices, empowering readers to implement robust quality management systems tailored to meet stringent FDA standards.
Product Details
- Written by an experienced medical device quality assurance professional
- Covers the requirements of FDA QSR 820, ISO 13485, and ISO 14971
- Includes information on manufacturing process validation and quality system development
- Provides guidance on Corrective and Preventive Action (CAPA)
- Discusses statistical techniques, process improvement, problem solving, and root cause analysis
- Written by a senior member of the American Society for Quality (ASQ) with professional certifications
| Publisher | CreateSpace Independent Publishing Platform |
| Publication date | December 19, 2015 |
| Language | English |
| Print length | 58 pages |
| ISBN-10 | 1522840249 |
| ISBN-13 | 978-1522840244 |
| Item Weight | 3.2 ounces (90.72 grams) |
| Dimensions | 6 x 0.14 x 9 inches (15.2 x 0.4 x 22.9 cm) |
Who Should Buy?
-
Quality Managers
A comprehensive guide for quality managers implementing FDA regulations and ensuring compliance within medical device companies.
-
Regulatory Consultants
Useful for consultants advising medical device companies on FDA regulations, facilitating easier comprehension of management controls.
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Medical Device Companies
Ideal reference for companies involved in medical device design and manufacturing, aiming for compliance with FDA quality standards.
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General Public
Not suitable for the general public, as it contains specialized technical information relevant only to professionals.
Product Description
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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Features & Benefits
- Highly knowledgeable in FDA QSR 820, ISO 13485, and ISO 14971 requirements.
- Expertise in manufacturing process validation and quality system development.
- Skilled in statistical techniques, process improvement, problem solving, and root cause analysis.
- Senior member of the American Society for Quality (ASQ) with multiple professional certifications.
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