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Pharmaceutical pre-approval inspecti...

United States., Food and Drug Administration.

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Pharmaceutical pre-approval inspections = a guide to regulatory success /

Record Type:	Electronic resources : Monograph/item
Title/Author:	Pharmaceutical pre-approval inspections/ edited by Martin D. Hynes III.
Reminder of title:	a guide to regulatory success /
other author:	Hynes, Martin D.
Published:	New York :informa healthcare, : 2008.,
Description:	x, 278 p. :ill.
[NT 15003449]:	1. The evolution of the food and drug administration : pre-new drug application approval inspection / Martin D. Hynes III and Jeanette M. Buckwalter -- 2. FDA's risk-based approach to inspections / Ronald F. Tetzlaff and Jeanette M. Buckwalter -- 3. Critical role of the pharmaceutical scientist in product development and preparing for pre-approval inspections / Mahdi Fawzi, Richard Saunders, and Parimal Desai -- 4. Training requirements in product development : a key to a successful pre-approval inspection / Tammy Chaney Cullen and Marie Crabb-Donat -- 5. The systems-based pre-approval inspection / Elizabeth M. Troll -- 6. A cGMP risk assessment and management strategy : guidelines for the pre-approval inspection / Carmen Medina -- 7. Concepts in quality by design for drug development and manufacture / Ken Morris and Ryan McCann -- 8. Equipment cleaning during pharmaceutical product development and its importance to pre-approval inspection / Lisa Ray -- 9. Conducting stability studies during development to ensure successful regulatory approval / Julianne Eggert and Carol Fowler -- 10. Computer systems validation during the drug development process in anticipation of pre-approval inspections / Ludwig Huber -- 11. Integral for successful PAI : the quality assessment program / Graham Bunn -- 12. All dressed up but no approval to go : the consequence of failing an FDA pre-approval inspection / Alan Minsk and David Hoffman.
Subject:	Drugs - Research - United States. -
Online resource:	http://marc.crcnetbase.com/isbn/9781420020489Distributed by publisher. Purchase or institutional license may be required for access.
ISBN:	9781420020489 (ebook : PDF)

Pharmaceutical pre-approval inspections = a guide to regulatory success /
Pharmaceutical pre-approval inspectionsa guide to regulatory success /[electronic resource] :edited by Martin D. Hynes III. - 2nd ed. - New York :informa healthcare,2008. - x, 278 p. :ill. - Drugs and the pharmaceutical sciences ;v. 181. - Drugs and the pharmaceutical sciences ;v. 183-184.

Includes bibliographical references and index.

1. The evolution of the food and drug administration : pre-new drug application approval inspection / Martin D. Hynes III and Jeanette M. Buckwalter -- 2. FDA's risk-based approach to inspections / Ronald F. Tetzlaff and Jeanette M. Buckwalter -- 3. Critical role of the pharmaceutical scientist in product development and preparing for pre-approval inspections / Mahdi Fawzi, Richard Saunders, and Parimal Desai -- 4. Training requirements in product development : a key to a successful pre-approval inspection / Tammy Chaney Cullen and Marie Crabb-Donat -- 5. The systems-based pre-approval inspection / Elizabeth M. Troll -- 6. A cGMP risk assessment and management strategy : guidelines for the pre-approval inspection / Carmen Medina -- 7. Concepts in quality by design for drug development and manufacture / Ken Morris and Ryan McCann -- 8. Equipment cleaning during pharmaceutical product development and its importance to pre-approval inspection / Lisa Ray -- 9. Conducting stability studies during development to ensure successful regulatory approval / Julianne Eggert and Carol Fowler -- 10. Computer systems validation during the drug development process in anticipation of pre-approval inspections / Ludwig Huber -- 11. Integral for successful PAI : the quality assessment program / Graham Bunn -- 12. All dressed up but no approval to go : the consequence of failing an FDA pre-approval inspection / Alan Minsk and David Hoffman.

Mode of access: World Wide Web.

ISBN: 9781420020489 (ebook : PDF)Subjects--Corporate Names:

758649
United States.
Food and Drug Administration.Subjects--Topical Terms:

1359637
Drugs
--Research--United States.Index Terms--Genre/Form:

542853
Electronic books.

Pharmaceutical pre-approval inspections = a guide to regulatory success /
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245 0 0 $a Pharmaceutical pre-approval inspections $h [electronic resource] : $b a guide to regulatory success / $c edited by Martin D. Hynes III.
250 $a 2nd ed.
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300 $a x, 278 p. : $b ill.
490 1 $a Drugs and the pharmaceutical sciences ; $v v. 181
504 $a Includes bibliographical references and index.
505 0 $a 1. The evolution of the food and drug administration : pre-new drug application approval inspection / Martin D. Hynes III and Jeanette M. Buckwalter -- 2. FDA's risk-based approach to inspections / Ronald F. Tetzlaff and Jeanette M. Buckwalter -- 3. Critical role of the pharmaceutical scientist in product development and preparing for pre-approval inspections / Mahdi Fawzi, Richard Saunders, and Parimal Desai -- 4. Training requirements in product development : a key to a successful pre-approval inspection / Tammy Chaney Cullen and Marie Crabb-Donat -- 5. The systems-based pre-approval inspection / Elizabeth M. Troll -- 6. A cGMP risk assessment and management strategy : guidelines for the pre-approval inspection / Carmen Medina -- 7. Concepts in quality by design for drug development and manufacture / Ken Morris and Ryan McCann -- 8. Equipment cleaning during pharmaceutical product development and its importance to pre-approval inspection / Lisa Ray -- 9. Conducting stability studies during development to ensure successful regulatory approval / Julianne Eggert and Carol Fowler -- 10. Computer systems validation during the drug development process in anticipation of pre-approval inspections / Ludwig Huber -- 11. Integral for successful PAI : the quality assessment program / Graham Bunn -- 12. All dressed up but no approval to go : the consequence of failing an FDA pre-approval inspection / Alan Minsk and David Hoffman.
530 $a Also available in print format.
538 $a Mode of access: World Wide Web.
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700 1 $a Hynes, Martin D. $3 1359636
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