Items related to Clinical Trials Audit Preparation: A Guide for Good...
Synopsis
A must-have guide for any professional in the drug manufacturing industry
The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards.
This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals.
Among the topics discussed:
-
Good Clinical Practices and therapeutic product development in clinical research
-
The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee
-
The roles and responsibilities of the clinical trial investigator
-
The inspection preparation
-
The Audit Report and the Form 483
-
Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development
"synopsis" may belong to another edition of this title.
About the Author
VERA MIHAJLOVIC-MADZAREVIC has more than twenty years of experience in scientific and clinical research in the academia and industry. She is the Director of Global Research Pharma Canada. She conducts Good Clinical Practice (GCP) audits for the pharmaceutical, biotech, and medical device industries worldwide in compliance with FDA, Health Canada, and other regulations. She also trains clinical and scientific personnel in GCP and clinical research, leading the Training and Professional Development Programs at the Clinical Research Institute of America (criamerica.com) and the Academy of Applied Pharmaceutical Sciences.
Review
"To help the reader, in addition to the detailed and meticulous discussions in the book's five chapters, appendices provide ready access to fundamental literature . . .Clinical Trials Audit Preparation is recommended to readers, and receives the JCS Library Award." (Journal for Clinical Studies, 1 November 2010)
"Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections" is a comprehensive manual for avoiding inspections, preparing for inspections, and being inspected. It is also a useful guide for inspectors." (Journal of Clinical Research Best Practices, 6 June 2011)
"About this title" may belong to another edition of this title.
- PublisherWiley
- Publication date2010
- ISBN 10 0470248858
- ISBN 13 9780470248850
- BindingHardcover
- Edition number1
- Number of pages272
Buy New
Learn more about this copy
US$ 112.45
Shipping:
US$ 2.64
Within U.S.A.
Top Search Results from the AbeBooks Marketplace
Seller Image
Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections
Seller: CSG Onlinebuch GMBH, Darmstadt, Germany
Seller rating 5 out of 5 stars
Kindle Edition. Condition: Gebraucht. Gebraucht - Wie neu Gebrauchtexemplar aus Rücksendung mit kleinem Fehler aus Versand. Zustand fast wie neu. Tagesaktueller, sicherer und weltweiter Versand. Wir liefern grundsätzlich mit beigelegter Rechnung. -A must-have guide for any professional in the drug manufacturing industryThe Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards.This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals.Among the topics discussed:\* Good Clinical Practices and therapeutic product development in clinical research\* The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee\* The roles and responsibilities of the clinical trial investigator\* The inspection preparation\* The Audit Report and the Form 483\* Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development. Seller Inventory # 39979
Quantity: 1 available
Seller Image
Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections
Seller: ZBK Books, Carlstadt, NJ, U.S.A.
Seller rating 5 out of 5 stars
Condition: good. Used book in good and clean conditions. Pages and cover are intact. Limited notes marks and highlighting may be present. May show signs of normal shelf wear and bends on edges. Item may be missing CDs or access codes. May include library marks. Fast Shipping. Seller Inventory # ZWM.4YOL
Quantity: 1 available
Stock Image
Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections
Seller: Book Deals, Tucson, AZ, U.S.A.
Seller rating 5 out of 5 stars
Condition: Good. Good condition. This is the average used book, that has all pages or leaves present, but may include writing. Book may be ex-library with stamps and stickers. 1.15. Seller Inventory # 353-0470248858-gdd
Quantity: 1 available
Stock Image
Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections
Seller: Books Unplugged, Amherst, NY, U.S.A.
Seller rating 5 out of 5 stars
Condition: Fair. Buy with confidence! Book is in acceptable condition with wear to the pages, binding, and some marks within 1.15. Seller Inventory # bk0470248858xvz189zvxacp
Quantity: 1 available
Stock Image
Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections
Seller: Book Deals, Tucson, AZ, U.S.A.
Seller rating 5 out of 5 stars
Condition: Fine. Like New condition. Great condition, but not exactly fully crisp. The book may have been opened and read, but there are no defects to the book, jacket or pages. 1.15. Seller Inventory # 353-0470248858-lkn
Quantity: 1 available
Seller Image
Clinical Trials Audit Preparation : A Guide for Good Clinical Practice (GCP) Inspections
Seller: GreatBookPrices, Columbia, MD, U.S.A.
Seller rating 5 out of 5 stars
Condition: New. Seller Inventory # 5288556-n
Quantity: 5 available
Stock Image
Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections
Seller: Lucky's Textbooks, Dallas, TX, U.S.A.
Seller rating 5 out of 5 stars
Condition: New. Seller Inventory # ABLIING23Feb2215580219415
Quantity: Over 20 available
Stock Image
Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections
Seller: Book Deals, Tucson, AZ, U.S.A.
Seller rating 5 out of 5 stars
Condition: Very Good. Very Good condition. Shows only minor signs of wear, and very minimal markings inside (if any). 1.15. Seller Inventory # 353-0470248858-vrg
Quantity: 1 available
Seller Image
Clinical Trials Audit Preparation : A Guide for Good Clinical Practice (GCP) Inspections
Seller: GreatBookPrices, Columbia, MD, U.S.A.
Seller rating 5 out of 5 stars
Condition: As New. Unread book in perfect condition. Seller Inventory # 5288556
Quantity: 5 available
Stock Image
Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections
Seller: Books Unplugged, Amherst, NY, U.S.A.
Seller rating 5 out of 5 stars
Condition: New. Buy with confidence! Book is in new, never-used condition 1.15. Seller Inventory # bk0470248858xvz189zvxnew
Quantity: 1 available