A Guide to Pharmacovigilance Audits in the USA / Heather Murphy.

Format:

Book

Author/Creator:

Murphy, Heather, author.

Language:

English

Subjects (All):

Pharmacovigilance--United States--Auditing.

Pharmacovigilance.

Physical Description:

1 online resource (153 pages)

Edition:

First edition.

Place of Publication:

Cham, Switzerland : Springer, [2024]

Summary:

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.

Contents:

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.

Notes:

Description based on print version record.

Includes bibliographical references and index.

Other Format:

Print version: Murphy, Heather A Guide to Pharmacovigilance Audits in the USA

ISBN:

9783031735967