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

Published: 2019-04-23

Total Pages: 633

ISBN-13: 0429525826

DOWNLOAD EBOOK

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, (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

Published: 2004-12-30

Total Pages: 452

ISBN-13: 0203026659

DOWNLOAD EBOOK

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

Author: Leonard Steinborn

Publisher:

Published: 2003

Total Pages:

ISBN-13: 9780429135941

DOWNLOAD EBOOK

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, (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

Published: 2019-08-30

Total Pages: 452

ISBN-13: 9780367393328

DOWNLOAD EBOOK

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

Published: 1999-06-30

Total Pages: 248

ISBN-13: 9781574910582

DOWNLOAD EBOOK

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.

Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy
Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy

Author: Mahmoud Aljurf

Publisher: Springer Nature

Published: 2021-02-19

Total Pages: 181

ISBN-13: 3030644928

DOWNLOAD EBOOK

This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program.

Pharmaceutical Manufacturing Handbook
Pharmaceutical Manufacturing Handbook

Author: Shayne Cox Gad

Publisher: John Wiley & Sons

Published: 2008-03-11

Total Pages: 1386

ISBN-13: 0470259809

DOWNLOAD EBOOK

This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Pharmaceutical Manufacturing Handbook
Pharmaceutical Manufacturing Handbook

Author: Shayne Cox Gad

Publisher: John Wiley & Sons

Published: 2008-04-04

Total Pages: 857

ISBN-13: 0470259825

DOWNLOAD EBOOK

With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.