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wyszukanych pozycji: 21
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Investigations Operations Manual: FDA Field Inspection and Investigation Policy and Procedure Concise Reference
ISBN: 9780982147627 / Angielski / Miękka / 2010 / 800 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. The IOM is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors. This extends to all individuals who perform field investigational activities in support of the Agency's public mission. Accordingly, it directs the conduct of all fundamental field investigational activities. Adherence to this manual is paramount to assure quality, consistency, and efficiency in field operations. The specific information in this manual is supplemented, not superseded, by other manuals and field guidance documents. The IOM is recommended reading for all...
The IOM is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors. This extends to all individua...
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240,74 |
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International Conference on Harmonisation (ICH) Quality Guidelines: Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference
ISBN: 9780982147658 / Angielski / Miękka / 2010 / 650 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. ICH Quality Guidelines: * Overview and Orientation * Introduction * Part I: Stability Q1A(R2), Q1B, Q1C, Q1D, Q1E] * Part II: Analytical Validation Q2(R1)] * Part III: Impurities Q3A(R2), Q3B(R2), Q3C(R4)] * Part IV: Pharmacopoeias (List Overview) * Part V: Quality of Biotechnological Products Q5A(R1), Q5B, Q5C, Q5D, Q5E] * Part VI: Specifications Q6A, Q6B] * Part VII: Good Manufacturing Practice Q7] * Part VIII: Pharmaceutical Development Q8(R2)] * Part IX: Quality Risk Management Q9] * Part X: Pharmaceutical Quality System Q10] Reference Tools * Part XI: Questions and Answers for...
ICH Quality Guidelines: * Overview and Orientation * Introduction * Part I: Stability Q1A(R2), Q1B, Q1C, Q1D, Q1E] * Part II: Analytical Validation ...
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180,55 |
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FDA Acronyms, Abbreviations and Terminology: Human and Veterinary Regulatory Reference
ISBN: 9780982147610 / Angielski / Miękka / 2010 / 426 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. FDA Acronyms, Abbreviations and Terminology provides a quick reference to the acronyms, abbreviations and definitions related to Food and Drug Administration (FDA) human and veterinary products regulatory activities. The emphasis for this reference guide is on scientific, regulatory, government agency, computer application terms, and includes some FDA organizational and program acronyms. Definitions from Title 21 of the United States Code have been included because of their relevance to FDA activities.
FDA Acronyms, Abbreviations and Terminology provides a quick reference to the acronyms, abbreviations and definitions related to Food and Drug Adminis...
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155,51 |
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Canadian Good Manufacturing Practices: Pharmaceutical, Biotechnology, and Medical Device Regulations and Guidance Concise Reference
ISBN: 9780982147641 / Angielski / Miękka / 2010 / 828 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. Part I: Food and Drugs Act - Part A: Administration - Part C: Drugs Division 1 - Division 1A: Establishment Licences - Division 2: Good Manufacturing Practices Part II: Guidance Documents Part III: Annexes to the Current Edition of the Good Manufacturing Practices (GMP) Guidelines Part IV: Questions and Answers Part V: International Conference on Harmonisation (ICH) Guidance Documents - ICH Q1A(R2): Stability Testing of New Drug Substances and Products - ICH Q1B: Stability Testing: Photostability Testing of New Drug Substances and Products - ICH Q1C: Stability Testing for New Dosage Forms -...
Part I: Food and Drugs Act - Part A: Administration - Part C: Drugs Division 1 - Division 1A: Establishment Licences - Division 2: Good Manufacturing ...
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200,61 |
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Good Manufacturing Practice (GMP) Guidelines: The Rules Governing Medicinal Products in the European Union, EudraLex Volume 4 Concise Reference
ISBN: 9780982147603 / Angielski / Miękka / 2009 / 686 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. This title combines all of the human and veterinary Regulations, Directives and guidance for medicinal products used by the pharmaceutical industry as their main source when manufacturing and distributing medicinal products in the European Union.
This title combines all of the human and veterinary Regulations, Directives and guidance for medicinal products used by the pharmaceutical industry as...
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220,68 |
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The Post-Surgical Pain Diary: Tracking Your Pain, Progress & Physical Therapy after Surgery
ISBN: 9781937258047 / Angielski / Miękka / 2011 / 166 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. After surgery, it is essential to track your level of pain and your progress through physical therapy. Receiving appropriate treatment for any medical condition requires providing complete and accurate information to your medical team. This book has been designed to collect comprehensive information tracking the process of healing after surgery with successful pain management. The needs of the patient, the clinician, and the many supportive members of the medical team (including the patient's family) are balanced to provide an easy reference tool with precise results. Each page provides a...
After surgery, it is essential to track your level of pain and your progress through physical therapy. Receiving appropriate treatment for any medical...
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116,34 |
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Navy Basic Military Requirements: Following the Model for Military Education
ISBN: 9780982147634 / Angielski / Miękka / 2003 / 740 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. The United States Navy Basic Military Requirements have long been the standard used as the pinnacle of training achievement. This manual has been continuously tested and updated to successfully educate every member of the Navy since its inception. The needs of the instructor, the student, and the Navy are perfectly balanced. Whether you are planning to join the Navy, have served in the Navy, or plan to use the BMR as a template for training material development, this book is for you. This is the model all educators should follow when developing training programs and course materials.
The United States Navy Basic Military Requirements have long been the standard used as the pinnacle of training achievement. This manual has been cont...
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220,68 |
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FDA Establishment Inspections: Pharmaceutical, Biotechnology, Medical Device and Food Manufacturing Concise Reference
ISBN: 9780982147665 / Angielski / Miękka / 2010 / 358 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. Establishment Inspections, Chapter 5 of the FDA's Investigations Operations Manual, details every step FDA inspectors are required to follow when conducting a facility inspection. This text is a comprehensive reference for regulatory inspections and is useful as an introduction to the practical components of the FDA-regulated industries or as a refresher. While the specific regulations and requirements may differ widely between pharmaceutical, biotechnology, medical device, and food manufacturers, the inspection processes and procedures do not.
Establishment Inspections, Chapter 5 of the FDA's Investigations Operations Manual, details every step FDA inspectors are required to follow when cond...
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132,39 |
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Current Good Manufacturing Practices: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference
ISBN: 9781449505233 / Angielski / Miękka / 2009 / 634 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. FDA Regulations and Associated Guidance Documents: - Part 11 Electronic Records; Electronic Signatures - Part 26 Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community - Part 200 Drugs General - Part 207 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution - Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs - Part 211 Current Good Manufacturing Practice...
FDA Regulations and Associated Guidance Documents: - Part 11 Electronic Records; Electronic Signatures - Part 26 Mutual Recognition of Pharmaceutical ...
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172,53 |
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The Pain Diary: Your Guide to Successful Pain Management
ISBN: 9781937258030 / Angielski / Miękka / 2011 / 296 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. Receiving appropriate treatment for any medical condition requires providing complete and accurate information to your medical team. Often, it will require more than one visit to more than one medical professional. Each visit requires completing similar forms and each of those professionals will likely ask many of the same questions, but with a slightly different focus. This book has been designed and tested to help shorten the frequently long and arduous process of diagnosing and successfully managing pain. The needs of the patient, the clinician, and the many supportive members of the...
Receiving appropriate treatment for any medical condition requires providing complete and accurate information to your medical team. Often, it will re...
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132,39 |
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Mountain Sundays
ISBN: 9781937258054 / Angielski / Miękka / 2011 / 46 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. Life is simple, family is important and good morals are still taught in these mountains and valleys. This book is an accurate depiction of life in rural Appalachia in the 1950s and, in some parts of the mountains, is still true today. This book is an ideal way for grandparents to relate life as it was when they were young to their grandchildren and to develop a connection between the past and the present.
Life is simple, family is important and good morals are still taught in these mountains and valleys. This book is an accurate depiction of life in rur...
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48,12 |
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Small Group Instructor Training Course (SGITC): Volume 1: Course Management Plan and Student Handbook
ISBN: 9780983071938 / Angielski / Miękka / 2011 / 768 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. The United States Army is recognized internationally as the standard for complete, efficient and effective adult education. The Army has a tradition of pioneering training systems (including computer-based training) that then transition into the corporate sector. This manual has been continuously tested and updated to successfully educate every member of the modern United States Army. The needs of the instructor, the student, and the Army are perfectly balanced. This is the model all educators should follow when developing and delivering training programs. This book is Volume 1 of a 2 volume...
The United States Army is recognized internationally as the standard for complete, efficient and effective adult education. The Army has a tradition o...
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220,68 |
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Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 2, Guidance
ISBN: 9780982147689 / Angielski / Miękka / 2010 / 752 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. Selected FDA GCP/Clinical Trial Guidance Documents Grouped by Topic: * FDA Overview and Orientation * Introduction to GCP * Part I: General * Part II: Institutional Review Boards (IRBs) and Informed Consent * Part III: Drugs and Biologics * Part IV: Medical Devices * Part V: Manufacturing Requirements for Investigational Products * Part VI: Electronic Data Reference Tools * Part VII: Combined Glossary and Index for all Quality Guidance Documents
Selected FDA GCP/Clinical Trial Guidance Documents Grouped by Topic: * FDA Overview and Orientation * Introduction to GCP * Part I: General * Part II:...
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196,60 |
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Good Laboratory Practice: Nonclinical Laboratory Studies Concise Reference
ISBN: 9780983071914 / Angielski / Miękka / 2010 / 276 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. This book is designed to be a unified reference source for the U.S. Food and Drug Adminstration's Good Laboratory Practice regulations, guidance, and associated documents for pharmaceutical, biologics and medical device products nonclinical trials. Good Laboratory Practice Regulations and Guidance: * FDA Overview and Orientation * Overview of GCP and Introduction to GLP * Part I: Federal Regulations Relating to Good Laboratory Practice o Parts 58: Good Laboratory Practice for Nonclinical Laboratory Studies o 1987 Final Rule - Good Laboratory Practice Regulations * Part II: Guidance Documents...
This book is designed to be a unified reference source for the U.S. Food and Drug Adminstration's Good Laboratory Practice regulations, guidance, and ...
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148,45 |
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Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 1, Regulati
ISBN: 9780982147672 / Angielski / Miękka / 2010 / 712 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. Topics covered include: * A brief description of the history and development of clinical research and good clinical practice * Title 21 CFR Parts 11, 50, 54, 56, 58, 210, 312, 314, 320, 511, 514, 601, 812, and 814 * FDA and ICH GCP Standards for Clinical Research * Form FDA 1572-Statement of Investigator * Informed Consent * Patient Recruitment * State Standards and GCP * Source Data/Documentation * Investigator/Site Requirements * Clinical Monitoring * Clinical Study Safety Reporting * Clinical Trial Protocols/Protocol Changes/Protocol Violations * Institutional Review Boards * Quality...
Topics covered include: * A brief description of the history and development of clinical research and good clinical practice * Title 21 CFR Parts 11, ...
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188,58 |
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Basic Human Anatomy & Physiology: Subcourses MD0006, MD0007; Edition 100
ISBN: 9780983071969 / Angielski / Miękka / 2008 / 598 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. In addition to providing the most concise information for efficiently learning basic human anatomy and physiology, this text also provides guided memorization exercises with complete answer keys for self-testing. The United States Army is recognized internationally as the standard for complete, efficient and effective adult education. The Army has a tradition of pioneering training systems that then transition into the corporate civilian sector. This manual has been continuously tested and updated to successfully educate every member of the modern United States Army Medical Department...
In addition to providing the most concise information for efficiently learning basic human anatomy and physiology, this text also provides guided memo...
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188,58 |
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Federal Food, Drug, and Cosmetic Act: The United States Federal FD&C Act Concise Reference
ISBN: 9780983071907 / Angielski / Miękka / 2010 / 672 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. This book is designed to be a unified reference source for the U.S. Federal Food, Drug, and Cosmetic Act and is designed to be used both as a reference for experienced industry representatives and as a training resource for those new to the industry. Federal Food, Drug, and Cosmetic Act: * Introduction to the FDA and the FD&C Act * Part I: Federal Food, Drug, and Cosmetic Act o Section Number Reference: Federal Food, Drug, and Cosmetic Act o FD&C Act Chapters I and II: Short Title and Definitions o FD&C Act Chapter III: Prohibited Acts and Penalties o FD&C Act Chapter IV: FoodFD&C Act Chapter...
This book is designed to be a unified reference source for the U.S. Federal Food, Drug, and Cosmetic Act and is designed to be used both as a referenc...
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196,60 |
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Small Group Instructor Training Course (SGITC): Volume 2: Training Support Packages
ISBN: 9780983071945 / Angielski / Miękka / 2011 / 336 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. The United States Army is recognized internationally as the standard for complete, efficient and effective adult education. The Army has a tradition of pioneering training systems (including computer-based training) that then transition into the corporate sector. This manual has been continuously tested and updated to successfully educate every member of the modern United States Army. The needs of the instructor, the student, and the Army are perfectly balanced. This is the model all educators should follow when developing and delivering training programs. This book is Volume 2 of a 2 volume...
The United States Army is recognized internationally as the standard for complete, efficient and effective adult education. The Army has a tradition o...
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cena:
140,42 |
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Navy Hospital Corpsman: NAVEDTRA 14295 Following the Model for Military Education
ISBN: 9780982147696 / Angielski / Miękka / 2004 / 728 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. This book includes both Hospital Corpsman NAVEDTRA 14295 and the Advancement Handbook for Hospital Corpsman. The United States Navy training programs have long been the standard used as the pinnacle of training achievement. The Hospital Corpsman training program has been continuously tested and updated to successfully educate every member of the Navy Hospital Corps since its inception. The needs of the instructor, the student, the patient, and the Navy are perfectly balanced. This is the model all educators should follow when developing training programs.
This book includes both Hospital Corpsman NAVEDTRA 14295 and the Advancement Handbook for Hospital Corpsman. The United States Navy training programs ...
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cena:
212,66 |
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Current Good Manufacturing Practices: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents, Concise Reference, Second Edit
ISBN: 9781937258177 / Angielski / Miękka / 2018 / 688 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. |
cena:
212,66 |
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