Mastering and managing the FDA maze : medical device overview, a training and management desk reference for manufacturers regulated by the Food and Drug Administration / Gordon Harnack.

Format:

Book

Author/Creator:

Harnack, Gordon, 1939- author.

Language:

English

Subjects (All):

United States. Food and Drug Administration Safety and Innovation Act.

United States.

Medical instruments and apparatus--Safety regulations--United States.

Medical instruments and apparatus.

Physical Description:

1 online resource (501 pages)

Edition:

2nd ed.

Place of Publication:

Milwaukee, Wisconsin : ASQ Quality Press, [2014]

Summary:

The number of FDA regulations and the agency's increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze!The target audiences for this desk reference include:Regulatory professionals, who know their responsibility to keep their firm's employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure complianceNeophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be usefulBeginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the jobIntermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detailBusy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activityBusy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions

Contents:

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

FDA Inspections

Chapter 3_Quality System Requirements, Management Responsibilities, and Personnel

Quality System

Subpart B-Quality System Requirements

FDA Inspection of Quality System Requirements

Chapter 4_Design Controls

Design Controls

FDA Inspections of Design Controls

Chapter 5_Document Controls

Document Controls

FDA Inspection of Document Controls

Chapter 6_Purchasing Controls

Purchasing Controls

FDA Inspection of Purchasing Controls

Chapter 7_Identification and Traceability

Identification and Traceability

FDA Inspection of Identification and Traceability

Chapter 8_Production and Process Controls

Production and Process Controls

FDA Inspection of Production and Process Controls

Chapter 9_Acceptance Activities

Acceptance Activities

FDA Inspection of Acceptance Activities

Chapter 10_Nonconforming Product

Nonconforming Product

FDA Inspection of Nonconforming Product

Chapter 11_Corrective and Preventive Action

Corrective and Preventive Action

FDA Inspection of Corrective and Preventive Action

Chapter 12_Statistical Techniques

Statistical Techniques

FDA Inspection of Statistical Techniques

Chapter 13_Device Master Record (DMR)

Device Master Record (DMR)

FDA Inspection of the Device Master Record

Chapter 14_Labeling and Packaging

Labeling

Device Labeling

Subpart K-Labeling and Packaging Control

FDA Inspection of Labeling

Packaging.

FDA Inspection of Packaging

Chapter 15_Handling, Storage, and Distribution

Handling

FDA Inspection of Handling

Storage

FDA Inspection of Storage

Distribution

Subpart L-Distribution

FDA Inspection of Distribution

Chapter 16_Installation and Servicing

Installation

FDA Inspection of Installation

Servicing

FDA Inspection of Servicing

Chapter 17_Records-General Requirements, Device History Record (DHR), and Quality System Record (QSR)

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

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

Unique Device Identification

FDA Inspection of Unique Device Identification

FDA Accredited UDI Organizations

Chapter 20_Medical Device Reporting

Medical Device Reporting

Chapter 21_Medical Devices-Reports of Corrections and Removals

Reports of Corrections and Removals

FDA Inspection of Corrections and Removals

Chapter 22_Quality Audit

Quality Audit

FDA Inspection of Auditing

Appendices

Appendix A

Appendix B

Appendix C

Appendix D

Appendix E

Appendix F

References and List of FDA Offices

Acronym List

Glossary

Index.

Notes:

Includes bibliographical references and index.

Description based on publisher supplied metadata and other sources.

Description based on print version record.

Other Format:

Print version: Harnack, Gordon Mastering and Managing the FDA Maze

ISBN:

9781636940465

OCLC:

1356006731