Author: Leonard Steinborn
Publisher: Interpharm CRC
ISBN: 9780935184655
Category : ISO 9000 Series Standards
Languages : en
Pages : 320

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Book Description

Author: Leonard Steinborn
Publisher: CRC Press
ISBN: 0203026659
Category : Medical
Languages : en
Pages : 453

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Book Description
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

Author: Leonard Steinborn
Publisher: CRC Press
ISBN: 0429525826
Category : Medical
Languages : en
Pages : 633

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Book Description
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

Author: Leonard Steinborn
Publisher: CRC Press
ISBN: 9780849318481
Category : ISO 9000 Series Standards
Languages : en
Pages :

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Book Description
This new edition continues a two-decade tradition of widely-used guidance for performing effective audits. Comprehensive in its coverage, this practical guide should prove a valuable tool that offers effective training for new auditors and updates current auditors on new standards and regulations. It helps defuse FDA inspectors frustration in not being able to view audit reports. When combined with a procedure, the checklists demonstrate that comprehensive auditing is part of the quality system.

Author: Oliver Schmidt
Publisher: CRC Press
ISBN: 142002602X
Category : Medical
Languages : en
Pages : 393

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Book Description
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

Author: Leonard Steinborn
Publisher: CRC Press
ISBN: 9780367393328
Category :
Languages : en
Pages : 452

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Book Description
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.

Author: Leonard Steinborn
Publisher: CRC Press
ISBN: 9781574910582
Category : Medical
Languages : en
Pages : 248

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Book Description
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.

Author:
Publisher:
ISBN:
Category : Medical publishing
Languages : en
Pages : 370

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Book Description

Author:
Publisher:
ISBN:
Category : Agricultural chemistry
Languages : en
Pages : 618

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Book Description

Author: Leonard Steinborn
Publisher: CRC Press
ISBN: 9780849318498
Category : Medical
Languages : en
Pages : 900

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Book Description
Are you compliance ready for 2003 and beyond? Have you audited against the following new standards and regulations? US CFR PART 11 Electronic Records and Signatures ISO 9001-2000 Quality Management Systems Requirements (replacement for ISO 9001, 9002 & 9003 -1994) ISO 13485/13488 Quality Systems - Medical Devices (replacements for EN46001 and EN46002) ISO 17025 General Requirements For The Competency Of Testing and Calibration Laboratories (replacement for EN 45001) And is your organization prepared for the latest US FDA inspection approach? QSIT - Quality System Inspection Technique If you are unsure, help is here - the sixth edition of the GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers. The world's most widely recognized QA manual has been updated to provide the audit system you need to assess compliance with these new standards/regulations and those that continue in effect. Additionally, the acclaimed author provides a checklist that simulates FDA QSIT audits. This new edition continues a two decade tradition of widely recognized and used guidance for performing effective audits. Comprehensive in its coverage, this practical guide is an invaluable tool that offers effective training for new auditors and updates current auditors on new standards and regulations. It helps defuse FDA inspectors frustration in not being able to view audit reports. When combined with a procedure, the checklists demonstrate that comprehensive auditing is part of the quality system.