Mastering and Managing the FDA Maze Medical Device Overview.
Clasificación: | Libro Electrónico |
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Autor principal: | |
Formato: | Electrónico eBook |
Idioma: | Inglés |
Publicado: |
La Vergne :
ASQ Quality Press,
2014.
|
Edición: | 2nd ed. |
Temas: | |
Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Cover
- Title page
- CIP data
- Contents
- Figures and Tables
- Acknowledgments
- What is New?
- Introduction
- Chapter 1_FDA Laws, Regulations, and Medical Device Oversight
- Scope
- FDA Laws
- FDA Regulations
- FDA Medical Device Oversight
- Chapter 2_FDA Inspections
- Scope
- FDA Inspections
- Chapter 3_Quality System Requirements, Management Responsibilities, and Personnel
- Scope
- Quality System
- Subpart B-Quality System Requirements
- FDA Inspection of Quality System Requirements
- Chapter 4_Design Controls
- Scope
- Design Controls
- FDA Inspections of Design Controls
- Chapter 5_Document Controls
- Scope
- Document Controls
- FDA Inspection of Document Controls
- Chapter 6_Purchasing Controls
- Scope
- Purchasing Controls
- FDA Inspection of Purchasing Controls
- Chapter 7_Identification and Traceability
- Scope
- Identification and Traceability
- FDA Inspection of Identification and Traceability
- Chapter 8_Production and Process Controls
- Scope
- Production and Process Controls
- FDA Inspection of Production and Process Controls
- Chapter 9_Acceptance Activities
- Scope
- Acceptance Activities
- FDA Inspection of Acceptance Activities
- Chapter 10_Nonconforming Product
- Scope
- Nonconforming Product
- FDA Inspection of Nonconforming Product
- Chapter 11_Corrective and Preventive Action
- Scope
- Corrective and Preventive Action
- FDA Inspection of Corrective and Preventive Action
- Chapter 12_Statistical Techniques
- Scope
- Statistical Techniques
- FDA Inspection of Statistical Techniques
- Chapter 13_Device Master Record (DMR)
- Scope
- Device Master Record (DMR)
- FDA Inspection of the Device Master Record
- Chapter 14_Labeling and Packaging
- Scope
- Labeling
- Device Labeling
- Subpart K-Labeling and Packaging Control
- FDA Inspection of Labeling
- Packaging
- FDA Inspection of Packaging
- Chapter 15_Handling, Storage, and Distribution
- Scope
- Handling
- FDA Inspection of Handling
- Storage
- FDA Inspection of Storage
- Distribution
- Subpart L-Distribution
- FDA Inspection of Distribution
- Chapter 16_Installation and Servicing
- Scope
- Installation
- FDA Inspection of Installation
- Servicing
- FDA Inspection of Servicing
- Chapter 17_Records-General Requirements, Device History Record (DHR), and Quality System Record (QSR)
- Scope
- Records
- Subpart M-General Requirements
- FDA Inspection of Records-General Requirements
- Subpart M-Device History Record (DHR)
- FDA Inspection of Device History Record
- Quality System Record
- FDA Inspection of the Quality System Record
- Chapter 18_Complaint Files
- Scope
- Complaint Files
- FDA Inspection of Complaint Files
- Chapter 19_Unique Device Identification (UDI) System Including Applicable Parts of 21 CFR 830 and 21 CFR 801
- Scope
- Unique Device Identification
- FDA Inspection of Unique Device Identification
- FDA Inspection of Labeling