business center
business management topics
business news
management systems
business products
management services
management and business services
customer service
management and business services

Business Topics
Management Systems
About Us
Contact Us

Books by Topic

FDA Code of Federal Regulation

Food and Drug Administration

Search CFR Title 21-Food and Drugs
(Code of Federa Regulatons)

Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices (Hardcover)
by Elaine Whitmore

This book is intended for anyone involved in pharmaceuticals, biologics, or medical devices. Helpful references include a glossary, acronyms, and a list of useful resources.

Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration by Gordon Harnack

This book will help you understand the regulations and be prepared for the FDA investigator.

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices (Hardcover)
by Kimberly A. Trautman

Compares the FDA Regulations and quality standard requirements.

Design Controls for the Medical Device Industry (Hardcover)
by Marie B. Teixeira

The guide to implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations.

ISO 13485:2003 & FDA QSR (21 CFR 820) Quality Manual, 34 Procedures and Forms (CD-ROM)
by Jack Kanholm

Template documentation on CD-ROM includes a quality manual, operational procedures, and forms. The documentation complies with both the international and US FDA regulations.

ISO 13485 (EN 46000) In Our Company, Self-Study Course for Personnel (Paperback)
by Jack Kanholm

The workbook is intended for training personnel in companies that either operate an ISO 13485 quality system or are implementing it and preparing for certification.

The Regulatory Compliance Almanac (Hardcover)
by Les Schnoll

A comprehensive guide to the regulations governing good manufacturing, clinical, and laboratory practices from the FDA, EPA, and the European Union.

Maintenance Management & Regulatory Compliance Strategies (Hardcover)
by Terry Wireman

A reference for implementing an effective maintenance management strategy to support the regulatory requirements..

Privacy Policy Copyright © 2000-2022 All Rights Reserved, Foqus, Inc., P.O. Box 910, New Smyrna Beach, FL 32170 Copyright