{"product_id":"clinical-trials-audit-preparation-a-guide-for-good-clinical-practice-gcp-inspections-hardcover","title":"Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections - Hardcover","description":"\u003cdiv\u003e\u003cp style=\"text-align: right;\"\u003e\u003ca href=\"https:\/\/reportcopyrightinfringement.com\/\" target=\"_blank\" rel=\"nofollow\"\u003e\u003cb\u003eReport copyright infringement\u003c\/b\u003e\u003c\/a\u003e\u003c\/p\u003e\u003c\/div\u003e\u003cp\u003eby \u003cb\u003eVera Mihajlovic-Madzarevic\u003c\/b\u003e (Author)\u003c\/p\u003e\u003ch3\u003eFront Jacket\u003c\/h3\u003e\u003cp\u003e\u003cb\u003eA must-have guide for any professional in the drug manufacturing industry\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eThe 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. \u003ci\u003eClinical Trials Audit Preparation\u003c\/i\u003e demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards.\u003c\/p\u003e \u003cp\u003eThis 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.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAmong the topics discussed: \u003c\/b\u003e\u003c\/p\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eGood Clinical Practices and therapeutic product development in clinical research\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eThe roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eThe roles and responsibilities of the clinical trial investigator\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eThe inspection preparation\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eThe Audit Report and the Form 483\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eWarning letters issued to clinical investigators and clinical trial sponsors and their impact on product development\u003c\/p\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003ch3\u003eAuthor Biography\u003c\/h3\u003e\u003cp\u003e\u003cb\u003eVERA MIHAJLOVIC-MADZAREVIC\u003c\/b\u003e 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.\u003c\/p\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003eNumber of Pages:\u003c\/strong\u003e 272\u003c\/div\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003eDimensions:\u003c\/strong\u003e 0.7 x 9.3 x 6.1 IN\u003c\/div\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003eIllustrated:\u003c\/strong\u003e Yes\u003c\/div\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003ePublication Date:\u003c\/strong\u003e June 08, 2010\u003c\/div\u003e\n            ","brand":"BooksCloud","offers":[{"title":"Default Title","offer_id":45343639601254,"sku":"9780470248850","price":183.64,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0599\/7255\/0758\/files\/YkRWN2xNZDRvTytWZWhkV0NFN2hYUT09.webp?v=1774943419","url":"https:\/\/infinitylightwa.com\/products\/clinical-trials-audit-preparation-a-guide-for-good-clinical-practice-gcp-inspections-hardcover","provider":"Infinity Light","version":"1.0","type":"link"}