Limit search to available items
Book Cover
E-book

Title Pharmaceutical pre-approval inspections : a guide to regulatory success / edited by Martin D. Hynes III
Edition 2nd ed
Published New York : Informa Healthcare, ©2008

Copies

Description 1 online resource (x, 278 pages) : illustrations
Series Drugs and the pharmaceutical sciences ; 181
Drugs and the pharmaceutical sciences ; v. 181.
Contents The evolution of the Food and Drug Administration: pre-new drug application approval inspection / Martin D. Hynes III and Jeanette M. Buckwalter -- FDA's risk-based approach to inspections / Ronald F. Tetzlaff and Jeanette M. Buckwalter -- Critical role of the pharmaceutical scientist in product development and preparing for pre-approval inspections / Mahdi Fawzi, Richard Saunders, and Parimal Desai -- Training requirements in product development: a key to a successful pre-approval inspection / Tammy Chaney Cullen and Marie Crabb-Donat -- The systems-based pre-approval inspection / Elizabeth M. Troll -- A cGMP risk assessment and management strategy: guidelines for the pre-approval inspection / Carmen Medina -- Concepts in quality by design for drug development and manufacture / Ken Morris and Ryan McCann -- Equipment cleaning during pharmaceutical product development and its importance to pre-approval inspection / Lisa Ray -- Conducting stability studies during development to ensure successful regulatory approval / Julianne Eggert and Carol Fowler -- Computer systems validation during the drug development process in anticipation of pre-approval inspections / Ludwig Huber -- Integral for successful PAI: the quality assessment program / Graham Bunn -- All dressed up but no approval to go: the consequence of failing an FDA pre-approval inspection / Alan Minsk and David Hoffman
Summary Offers a guide to prepare for inspections - taking into account, the trends in FDA expectations and enforcement activities, such as quality systems-based approach to inspections and risk-based inspections
Notes Revised edition of: Preparing for FDA pre-approval inspections. ©1999
Bibliography Includes bibliographical references and index
Notes Print version record
Subject United States. Food and Drug Administration.
SUBJECT United States. Food and Drug Administration fast
Subject Drugs -- Research -- Standards -- United States
Drug Industry -- standards
Drug Approval
Laboratories -- standards
MEDICAL -- Drug Guides.
MEDICAL -- Pharmacology.
MEDICAL -- Pharmacy.
MEDICAL -- Nursing -- Pharmacology.
Drugs -- Research -- Standards
SUBJECT United States
Subject United States
Form Electronic book
Author Hynes, Martin D.
ISBN 9781420020489
142002048X
9780849391842
0849391849
OTHER TI Preparing for FDA pre-approval inspections