02774nam a22005175i 4500 978-3-031-73596-7 DE-He213 20251030113301.0 cr nn 008mamaa 241107s2024 sz | s |||| 0|eng d 9783031735967 978-3-031-73596-7 10.1007/978-3-031-73596-7 doi RM300-666 MMG bicssc MED071000 bisacsh MKG thema Murphy, Heather. author. aut http://id.loc.gov/vocabulary/relators/aut 87142 A Guide to Pharmacovigilance Audits in the USA [electronic resource] / by Heather Murphy. 1st ed. 2024. Cham : Springer Nature Switzerland : Imprint: Springer, 2024. XII, 146 p. online resource. text txt rdacontent computer c rdamedia online resource cr rdacarrier text file PDF rda 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. Pharmacology. 67844 Pharmaceutical chemistry. 67843 Pharmacy. 64666 Pharmacology. 67844 Pharmaceutics. 67846 Pharmacy. 64666 SpringerLink (Online service) Springer Nature eBook Printed edition: 9783031735950 Printed edition: 9783031735974 Printed edition: 9783031735981 https://doi.org/10.1007/978-3-031-73596-7 ZDB-2-SBL ZDB-2-SXB 64772 64772