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A guide to pharmacovigilance audits in the USA

Record Type:	Electronic resources : Monograph/item
Title/Author:	A guide to pharmacovigilance audits in the USA/ by Heather Murphy.
Author:	Murphy, Heather.
Published:	Cham :Springer Nature Switzerland : : 2024.,
Description:	xii, 146 p. :ill., digital ;24 cm.
[NT 15003449]:	Chapter 1 Introduction -- Chapter 2 Audit Types -- Chapter 3 PV Audit Preparation -- Chapter 4 PV Audit Conduct -- Chapter 5 Audit Report -- Chapter 6 Dos and Don'ts of a successful audit.
Contained By:	Springer Nature eBook
Subject:	Pharmacovigilance - Auditing. - United States -
Online resource:	https://doi.org/10.1007/978-3-031-73596-7
ISBN:	9783031735967

A guide to pharmacovigilance audits in the USA
Murphy, Heather.

A guide to pharmacovigilance audits in the USA[electronic resource] /by Heather Murphy. - Cham :Springer Nature Switzerland :2024. - xii, 146 p. :ill., digital ;24 cm.

Chapter 1 Introduction -- Chapter 2 Audit Types -- Chapter 3 PV Audit Preparation -- Chapter 4 PV Audit Conduct -- Chapter 5 Audit Report -- Chapter 6 Dos and Don'ts of a successful audit.

Pharmacovigilance Audits are an important and growing requirement for Pharmaceutical/BioTech companies. A niche skillset combined with an understanding of audit principles and pharmacovigilance operational and regulatory knowledge are required to effectively conduct these audits This book provides practical guidance to auditors as to what questions to ask, what information to look for, and what documents to request to ensure the auditee Pharmacovigilance System is compliant with regulations, contractual requirements, and industry best practice. The scope is limited to the requirements based on the US Food and Drug Administration (FDA) Regulations. This is an ideal book for auditors and auditees who want to obtain practical PV auditing skills to use within the BioTechnology/Pharmaceutical Industry in the USA.

ISBN: 9783031735967

Standard No.: 10.1007/978-3-031-73596-7doiSubjects--Topical Terms:

3734264
Pharmacovigilance
--Auditing.--United States

LC Class. No.: RM302.5

Dewey Class. No.: 615.7042

A guide to pharmacovigilance audits in the USA
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505 0 $a Chapter 1 Introduction -- Chapter 2 Audit Types -- Chapter 3 PV Audit Preparation -- Chapter 4 PV Audit Conduct -- Chapter 5 Audit Report -- Chapter 6 Dos and Don'ts of a successful audit.
520 $a Pharmacovigilance Audits are an important and growing requirement for Pharmaceutical/BioTech companies. A niche skillset combined with an understanding of audit principles and pharmacovigilance operational and regulatory knowledge are required to effectively conduct these audits This book provides practical guidance to auditors as to what questions to ask, what information to look for, and what documents to request to ensure the auditee Pharmacovigilance System is compliant with regulations, contractual requirements, and industry best practice. The scope is limited to the requirements based on the US Food and Drug Administration (FDA) Regulations. This is an ideal book for auditors and auditees who want to obtain practical PV auditing skills to use within the BioTechnology/Pharmaceutical Industry in the USA.
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