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A Guide to Pharmacovigilance Audits in the USA

By Heather Murphy

A Guide to Pharmacovigilance Audits in the USA Medicine

A Guide to Pharmacovigilance Audits in the USA

0 - Default Title
Description
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.
Product details
Binding:
Paperback
Number of Pages:
160
Release Date:
2025-11-09
Publication Date:
2025-11-09
Publisher:
Springer
Languages:
Original: English
ISBN10:
3031735986
ISBN13:
9783031735981
GPSR Manufacturer Reference:
[email protected]
Weight:
254 g
Height:
155 cm
Width:
235 cm
Thickness:
9 cm
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