Author: Publisher:
ISBN:
Category :
Languages : en
Pages :
Book Description
An FDA Inspector Calls
Author: An FDA Inspector Calls
Author: Aruna Rani VenkateswaranPublisher:
ISBN: 9781904255031
Category : Clinical trials
Languages : en
Pages : 40
Book Description
FDA Papers
Author: 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.
Diminished Capacity: Can the FDA Assure the Safety and Security of the Nation's Food Supply? Serial No. 110-33 Part A, April 24 and July 17, 2007, 110-1 Hearings, *
Author: FDA Consumer
Author: The Cosmetic Industry
Author: EstrinPublisher: Routledge
ISBN: 135141089X
Category : Medical
Languages : en
Pages : 734
Book Description
This book summarizes the authority of regulatory agencies and programs as they pertain to the cosmetic industry, offers practical advice on how to operate within the regulatory environment, and introduces scientific and regulatory issues that are likely to have an impact on cosmetic manufacturers. "This interesting volume reports all the novel technologies in use to study and control the cosmetic products in order to make them effective and free of side effects." ---Journal of Applied Cosmetology, 2000
Handbook of Bioequivalence Testing
Author: Sarfaraz K. NiaziPublisher: CRC Press
ISBN: 1482226383
Category : Medical
Languages : en
Pages : 1007
Book Description
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have m
FDA Inspector
Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category : Cosmetics
Languages : en
Pages : 12
Book Description
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