A Guide to Pharmacovigilance Audits in the USA
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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.
Format:Hardcover
Language:English
ISBN:3031735951
ISBN13:9783031735950
Release Date:November 2024
Publisher:Springer
Length:146 Pages
Weight:0.86 lbs.
Dimensions:0.6" x 6.5" x 9.4"
Related Subjects
Medical Medical Books Science Science & Math Science & Scientists Science & TechnologyCustomer Reviews
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