GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines)

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines)
Author: Leonard Steinborn
Publisher: CRC Press
Total Pages: 452
Release: 2004-12-30
Genre: Medical
ISBN: 0203026659

This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations* EC and IPEC guidelines* ISO/BSI standards referenced in the checklists furnished in volume 1Easy-to-read and organized to provide fa

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

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 1 - With Checklists and Software Package)
Author: Leonard Steinborn
Publisher: CRC Press
Total Pages: 633
Release: 2019-04-23
Genre: Medical
ISBN: 0429525826

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

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers
Author: Leonard Steinborn
Publisher:
Total Pages:
Release: 2003
Genre: MEDICAL
ISBN: 9780429135941

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

Pharmaceutical Quality Systems

Pharmaceutical Quality Systems
Author: Oliver Schmidt
Publisher: CRC Press
Total Pages: 393
Release: 2000-04-30
Genre: Medical
ISBN: 142002602X

When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guideline that define exactly how such a system has to be built. With terms such as quality system, quality assurance, and quality management used interchangeably, even defining the system's objectives is a problem. This book provides a pr

Gmp/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines)

Gmp/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines)
Author: Leonard Steinborn
Publisher: CRC Press
Total Pages: 452
Release: 2019-08-30
Genre:
ISBN: 9780367393328

This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations * EC and IPEC guidelines * ISO/BSI standards referenced in the checklists furnished in volume 1 Easy-to-read and organized to provide fast access to guidelines and regulations, this is an essential reference for those working in the field.

GMP/ISO/EN Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Fifth Edition, (Volume I - Checklists)

GMP/ISO/EN Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Fifth Edition, (Volume I - Checklists)
Author: Leonard Steinborn
Publisher: CRC Press
Total Pages: 248
Release: 1999-06-30
Genre: Medical
ISBN: 9781574910582

The world's most widely recognized QA manual, GMP/ISO/EN Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, has been updated to provide the audit system you need to assess compliance with current standards and regulations. The Fifth Edition continues a nearly two-decade long tradition of widely recognized and utilized guidance for performing effective audits against regulations and guidelines.