GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 1 - With Checklists and Software Package)

by Leonard Steinborn

Overview

Volume 1 of this two-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these

Product Details

ISBN-13:	9780429525827
Publisher:	CRC Press
Publication date:	04/23/2019
Sold by:	Barnes & Noble
Format:	eBook
Pages:	448
File size:	58 MB
Note:	This product may take a few minutes to download.

About the Author

Leonard Steinborn

Table of Contents

VOLUME 1 includes checklists for: Internal Device Manufacturer/Developer, Internal Drug Manufacturer/Developer, Contract Device Manufacturer/Developer, Contract Drug Manufacturer/Developer, Contract Software Developer, General Supplier, Chemical Supplier, Printed Material Supplier, Electronic Component Supplier, Simulated QSIT Audit (FDA Approach), and New Product Market Launch - all referenced to the relevant FDA regs, EC and IPEC guidelines, and ISO/BSI standards. It also includes complete explanation of audit types, their advantages/disadvantages, do's and don'ts for auditors and guidance for audit preparation, performance, conclusion, report derivation and follow up activities. VOLUME 2 contains full texts of the regulations, standards, and guidelines referenced in Volume I.