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
See More Details
Description: Back to School Promotion at eBooks.com. 12% off Academic book titles. Landing page is on our academics category page. Static image.
Back to School Promotion at eBooks.com. 12% off Academic book titles. Landing page is on our academics category page. Static image.
See More Details
Description: Purchase textbooks at student discounts!
Purchase textbooks at student discounts!
Available to 2020-12-31 06:04:00
See More Details
Description: 20% Off these Categories- Body Mind & Spirit, Family & Relationships, Foreign Language Study, History, Sports & Recreation. Offer Lasts all through January.
20% Off these Categories- Body Mind & Spirit, Family & Relationships, Foreign Language Study, History, Sports & Recreation. Offer Lasts all through January.
Reflow text when sidebars are open.
