A Guide to Pharmacovigilance Audits in the USA
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- Hardcover
- Taschenbuch ausgewählt
- eBook
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Sprache:Englisch
Fr. 137.00
inkl. gesetzl. MwSt.,
Beschreibung
Produktdetails
Einband
Taschenbuch
Erscheinungsdatum
09.11.2025
Abbildungen
XII, 146 p.
Verlag
SpringerSeitenzahl
146
Maße (L/B/H)
23.5/15.5/0.9 cm
Gewicht
254 g
Sprache
Englisch
ISBN
978-3-031-73598-1
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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