Author: Michael CutterPublisher:
ISBN: 9780935184884
Category : Medical instruments and apparatus industry
Languages : en
Pages : 32
Book Description
How to Prepare for an FDA Inspection
Author: Michael CutterPublisher:
ISBN: 9780935184884
Category : Medical instruments and apparatus industry
Languages : en
Pages : 32
Book Description
GMP "How To" Essentials
Author: Michael CutterPublisher: Interpharm CRC
ISBN: 9780935184891
Category :
Languages : en
Pages : 150
Book Description
FDA Investigations Operations Manual
Author: Food and Drug AdministrationPublisher:
ISBN: 9780865879737
Category : Drugs
Languages : en
Pages : 0
Book Description
Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.
Clinical Trials Audit Preparation
Author: Vera Mihajlovic-MadzarevicPublisher: John Wiley & Sons
ISBN: 0470920882
Category : Medical
Languages : en
Pages : 186
Book Description
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
Survival Guide to FDA Inspections
Author: FDA Biotechnology Inspection Guide
Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category : Biotechnology
Languages : en
Pages : 62
Book Description
Preparing for FDA Pre-Approval Inspections
Author: Martin D. HynesPublisher: CRC Press
ISBN: 1000654370
Category : Medical
Languages : en
Pages : 310
Book Description
This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. Th
Preparing for FDA Pre-Approval Inspections
Author: Martin D. HynesPublisher: CRC Press
ISBN: 9780824702182
Category : Medical
Languages : en
Pages : 302
Book Description
This one-of-a-kind reference clarifies FDA requirements for the manufacture of clinical trial material as well as product development activities and suggests strategies that will facilitate FDA authorization to market.
Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 0309172802
Category : Medical
Languages : en
Pages : 88
Book Description
In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
An FDA Inspector Calls
Author: Aruna Rani VenkateswaranPublisher:
ISBN: 9781904255031
Category : Clinical trials
Languages : en
Pages : 40
Book Description