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wyszukanych pozycji: 14
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Principles of Process validation: A handbook for professionals in Medical Device, Pharmaceutical, and Biomedical Industries.
ISBN: 9781452843186 / Angielski / Miękka / 2010 / 120 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. This book discusses the verious principles governing process validation.It introduces concepts and breaks the concepts down to a level any reader can understand.
This book discusses the verious principles governing process validation.It introduces concepts and breaks the concepts down to a level any reader can ...
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cena:
262,48 |
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Principles of Design controls for Medical Device: A handbook for Professionals in the Medical Device Industry
ISBN: 9781470173661 / Angielski / Miękka / 2012 / 102 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. A Refence book for Quality Engineers, Quality Managers, and Design Engineers in the medical device industry
A Refence book for Quality Engineers, Quality Managers, and Design Engineers in the medical device industry
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cena:
262,48 |
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Principles of Corrective Action and Preventive Action: CAPA: A Handbook for Quality Professionals in the Pharmaceutical and Medical Device Industries
ISBN: 9781981403714 / Angielski / Miękka / 2017 / 76 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. |
cena:
378,11 |
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HOW TO DESIGN A WORLD-CLASS Corrective Action Preventive Action SYSTEM FOR FDA-REGULATED INDUSTRIES: A Handbook for Quality Engineers and Quality Mana
ISBN: 9781425950538 / Angielski / Miękka / 2006 / 104 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. The CAPA (Corrective Action/Preventive Action) Quality subsystem is the most audited by FDA inspectors. This book is designed to help Quality management professionals in Biomedical, Pharmaceutical, Tissue, and Medical Device industries design a CAPA Quality subsystem that meets and exceeds CAPA requirements in 21CFR 820.100(J).This book accomplishes the following: Defines CAPA Provides cross-functional process flows Provides requirements for a CAPA system Provides examples for the document hierarchy needed Provides definitions for a CAPA system Provides examples of work instructions, and...
The CAPA (Corrective Action/Preventive Action) Quality subsystem is the most audited by FDA inspectors. This book is designed to help Quality manageme...
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cena:
162,38 |
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How to Write Standard Operating Procedures and Work Instructions: A Handbook for Quality Managers and Quality Engineers
ISBN: 9781452828206 / Angielski / Miękka / 2010 / 90 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. This book is designed to help Quality system professionals learn how to write Quality system documents.It takes away the confusion between work Instructions and Standard operating procedures.This book also helps the reader to design a robust Quality management system.
This book is designed to help Quality system professionals learn how to write Quality system documents.It takes away the confusion between work Instru...
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cena:
262,48 |
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How to design a Pharmaceutical Quality system that meets Compliance requirements.: A handbook for professionals in the Pharmaceutical industry
ISBN: 9781470169176 / Angielski / Miękka / 2012 / 196 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. A handbook for Quality Professionals in the Pharmaceutical Industry
A handbook for Quality Professionals in the Pharmaceutical Industry
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cena:
380,29 |
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Principles of change control: A handbook for Quality and regulatory professionals
ISBN: 9780615746395 / Angielski / Miękka / 2013 / 96 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. A handbook for professionals in the medical device, Pharmaceutical, and Biotechnology industri
A handbook for professionals in the medical device, Pharmaceutical, and Biotechnology industri
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cena:
342,08 |
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How To Perform Process Validation: A cGMP GUIDE FOR QUALITY ENGINEERS
ISBN: 9781449512378 / Angielski / Miękka / 2009 / 78 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. THIS QUICK REFERENCE GUIDE IS MEANT TO HELP INDIVIDUALS PERFORMING PROCESS VALIDATION TO COVER ALL PHASES OF THE VALIDATION LIFE CYCLE, AND ALL ACTIVITIES REQUIRED PER PHASE IN ORDER TO BE IN COMPLIANC
THIS QUICK REFERENCE GUIDE IS MEANT TO HELP INDIVIDUALS PERFORMING PROCESS VALIDATION TO COVER ALL PHASES OF THE VALIDATION LIFE CYCLE, AND ALL ACTIVI...
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cena:
190,84 |
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Change Control for FDA Regulated Industries: A Risk Assesment Approach
ISBN: 9781434314673 / Angielski / Miękka / 2007 / 148 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. This book accomplishes the following: .It addresses requirements for Pharmaceutical, Medical Device, Biologics, and Tissue banking change control .Defines the different phases of the change control life cycle .Establishes the relationship between risk management, cost of doing business and change control .Defines regulatory requirements for change control, including requirements for (510k) submission .Provides tools for risk assesment, and cost/benefit analysis .Helps the reader design a Change control system that meets and exceeds cGMP requir
This book accomplishes the following: .It addresses requirements for Pharmaceutical, Medical Device, Biologics, and Tissue banking change control .Def...
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cena:
135,32 |
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Designing a World-Class Quality Management System for FDA Regulated Industries: Quality System Requirements (Qsr) for Cgmp
ISBN: 9781434348722 / Angielski / Twarda / 2008 / 132 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. This book accomplishes the following for you: 1.It helps you design a Quality management system that meets and exceeds QSR requirements. 2.It helps you understand requirements for the design of a Quality Management system for Medical Device, Pharmaceutical, Tissue, and Biomedical industries 3.It provides the Quality system document structure 4.It helps you understand Quality system requirements for ISO 13485, and ISO 9001 5.It provides standard definitions for the Quality management system 6.It gives you examples of Quality system related warning letters written by the FDA during onsite audi
This book accomplishes the following for you: 1.It helps you design a Quality management system that meets and exceeds QSR requirements. 2.It helps yo...
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cena:
216,51 |
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Designing a World-Class Quality Management System for FDA Regulated Industries: Quality System Requirements (Qsr) for Cgmp
ISBN: 9781434348715 / Angielski / Miękka / 2008 / 132 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. This book accomplishes the following for you: 1.It helps you design a Quality management system that meets and exceeds QSR requirements. 2.It helps you understand requirements for the design of a Quality Management system for Medical Device, Pharmaceutical, Tissue, and Biomedical industries 3.It provides the Quality system document structure 4.It helps you understand Quality system requirements for ISO 13485, and ISO 9001 5.It provides standard definitions for the Quality management system 6.It gives you examples of Quality system related warning letters written by the FDA during onsite audits
This book accomplishes the following for you: 1.It helps you design a Quality management system that meets and exceeds QSR requirements. 2.It helps yo...
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cena:
189,45 |
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Change Control for FDA Regulated Industries: A Risk Assesment Approach
ISBN: 9781434314680 / Angielski / Twarda / 2007 / 148 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. This book accomplishes the following: .It addresses requirements for Pharmaceutical, Medical Device, Biologics, and Tissue banking change control .Defines the different phases of the change control life cycle .Establishes the relationship between risk management, cost of doing business and change control .Defines regulatory requirements for change control, including requirements for (510k) submission .Provides tools for risk assesment, and cost/benefit analysis .Helps the reader design a Change control system that meets and exceeds cGMP requirements
This book accomplishes the following: .It addresses requirements for Pharmaceutical, Medical Device, Biologics, and Tissue banking change control .Def...
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cena:
157,88 |
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Basic Clean Room Protocol: How to gown for the clean room
ISBN: 9781461178408 / Angielski / Miękka / 2011 / 54 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. A step by step gowning procedure for the clean room
A step by step gowning procedure for the clean room
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cena:
262,48 |
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How to write standard operating procedures and work Instructions.2ND EDITION: A handbook for Quality Managers and Quality Engineers.
ISBN: 9781475061345 / Angielski / Miękka / 2012 / 106 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. This second edition contains two additional chapters on Good Documentation Practices(GDPs).
This second edition contains two additional chapters on Good Documentation Practices(GDPs).
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cena:
260,89 |
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