A Murphy, Heather. creator author. aut http://id.loc.gov/vocabulary/relators/aut SpringerLink (Online service) text sz 2024 1st ed. 2024. monographic eng

electronic

electronic resource

access XII, 146 p. online resource. 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. 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. by Heather Murphy. Pharmacology Pharmaceutical chemistry Pharmacy Pharmacology Pharmaceutics Pharmacy RM300-666 9783031735967 https://doi.org/10.1007/978-3-031-73596-7 https://doi.org/10.1007/978-3-031-73596-7 241107 20251030113301.0 978-3-031-73596-7